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BACKGROUND AND OBJECTIVE: To identify the proportion of patients with retinal vein occlusion (RVO) with loss to follow-up (LTFU) along with potential risk factors after receiving an intravitreal anti-vascular endothelial growth factor (VEGF) injection. PATIENTS AND METHODS: A retrospective review based on billing codes was performed from January 1, 2012, to January 1, 2017. LTFU was defined as no office visit within 12 months following an intravitreal injection. Potential risk factors for LTFU were screened using univariate analysis for inclusion in a final multivariate logistic regression model. RESULTS: A total of 3,400 unique patients with RVO with macular edema met the study inclusion criteria. Of these, 863 patients (25.4%) were LTFU. Rates of LTFU varied based on race / ethnicity, age, RVO type, distance from clinic, insurance status, and regional average adjusted gross income. In the multivariate analysis, patients with LTFU were more likely to be black (odds ratio [OR] = 1.37), Hispanic (OR = 2.37), and living more than 20 miles away from clinic (OR = 1.47). Patients who were 65 to 80 years old (OR = 0.71) and those with branch retinal vein occlusion (OR = 0.70) were less likely to be LTFU. Subgroup analysis showed that patients with baseline visual acuity better than 20/50 were also less likely to be LTFU. CONCLUSIONS: Approximately one in four patients did not return for a year or more after receiving an intravitreal injection for RVO. Given the importance of ongoing therapy to prevent vision loss, these “real-world” findings are of significant concern. [ Ophthalmic Surg Lasers Imaging Retina . 2019;50:159–166.]

Purpose Retinal vascular occlusion is a leading cause of profound irreversible visual loss, but the understanding of the disease is insufficient. We systematically investigated the age, gender, and laterality at the onset of retinal artery occlusion (RAO) and retinal vein occlusion (RVO) in the Intelligent Research in Sight (IRIS®) Registry. Design Retrospective registry cohort. Participants Patients with retinal vascular occlusion participating in the IRIS® Registry. Methods Patients who received a diagnosis of retinal vascular occlusion between 2013 and 2017 were included. Those with unspecified gender or laterality were excluded when conducting the relevant analyses. Patients were categorized into RAO, with subtypes transient retinal artery occlusion (TRAO), partial retinal artery occlusion (PRAO), branch retinal artery occlusion (BRAO), and central retinal artery occlusion (CRAO), and into RVO, with subtypes venous engorgement (VE), branch retinal vein occlusion (BRVO), and central retinal vein occlusion (CRVO). Age was evaluated as a categorical variable (5-year increments). We investigated the association of age, gender, and laterality with the onset frequency of retinal vascular occlusion subtypes. Main Outcome Measures The frequency of onset of RAO and RVO subtypes by age, gender and laterality. Results A total of 1 251 476 patients with retinal vascular occlusion were included, 23.8% of whom had RAO, whereas 76.2% had RVO. Of these, 1 248 656 and 798 089 patients were selected for analyses relevant to gender and laterality, respectively. The onset frequency of all subtypes increased with age. PRAO, BRAO, CRAO, and CRVO presented more frequently in men (53.5%, 51.3%, 52.6%, and 50.4%, respectively), whereas TRAO, VE, and BRVO presented more frequently in women (54.9%, 56.0%, and 54.5% respectively). All RAO subtypes and BRVO showed a right-eye onset preference (TRAO, 51.7%; PRAO, 54.4%; BRAO, 53.5%; CRAO, 53.4%; and BRVO, 51.0%), whereas VE and CRVO exhibited a left-eye onset preference (53.3% and 50.9%, respectively). Conclusions Although retinal vascular occlusion incidence increases with age regardless of subtypes, we found various subtype-specific disease-onset differences related to gender and, in particular, ocular laterality. These findings may improve understanding of the specific cause of retinal vascular occlusions of different subtypes and their relationships with structural and anatomic asymmetries of the vascular system.

This study characterizes differences in glaucomatous eyes with and without high axial myopia using custom automated analysis of OCT images. 452 eyes of 277 glaucoma patients were stratified into non (n = 145 eyes), mild (n = 214 eyes), and high axial myopia (axial length (AL) > 26 mm, n = 93 eyes). Optic disc ovality index, tilt and rotation angle of Bruch´s membrane opening (BMO) and peripapillary choroidal thickness (PCT) were calculated using automated and deep learning strategies. High myopic optic discs were more oval and had larger BMO tilt than mild and non-myopic discs (both p p p

Loss to follow-up (LTFU) may contribute to vision loss in patients with active proliferative diabetic retinopathy (PDR). The aim of this study is to determine and compare the rates of LTFU in patients with PDR receiving panretinal photocoagulation (PRP) or intravitreal injections (IVIs) with anti-vascular endothelial growth factor (VEGF) over approximately 4 years. Moreover, this study evaluates various risk factors for LTFU.Retrospective cohort study.A total of 2302 patients with PDR receiving IVIs with anti-VEGF or PRP between January 1, 2012, and April 20, 2016.Intervals between each procedure and the subsequent follow-up visit were measured. Loss to follow-up was defined as at least 1 interval exceeding 12 months duration.The LTFU rates and associated risk factors.A total of 1718 patients (74.6%) followed up postprocedure and 584 patients (25.4%) were LTFU over approximately 4 years. Of the patients receiving PRP, 28.0% were LTFU compared with 22.1% of patients receiving IVI with anti-VEGF (P = 0.001). The LTFU rates decreased as age increased, with rates of 28.1% for patients aged ≤55 years, 27.0% for patients aged 56 to 65 years, and 20.9% for patients aged65 years (P = 0.002). Loss to follow-up also differed by race, with rates of 19.4% for whites, 30.2% for African Americans, 19.7% for Asians, 38.0% for Hispanics, Native Americans, and Pacific Islanders, and 34.9% for patients of unreported race (P0.001). The LTFU rates also increased as regional average adjusted gross incomes (AGIs) decreased, with rates of 33.9% for patients with regional average AGI of ≤$40 000, 24.0% for patients with regional average AGI from $41 000 to $80 000, and 19.7% for patients with regional average AGI$80 000 (P 0.001). Procedure type, age, race, and regional average AGI were all significant (P0.05) independent risk factors of LTFU in the multivariate regression.A large proportion of patients with PDR were LTFU after receiving PRP or an anti-VEGF injection over approximately 4 years. Key risk factors included age, race, and regional average AGI.

Purpose High-quality optical coherence tomography (OCT) macular scans make it possible to distinguish a range of normal and diseased states by characterising foveal pit shape. Existing mathematical models lack the flexibility to capture all known pit variations and thus characterise the pit with limited accuracy. This study aimed to develop a new model that provides a more robust characterisation of individual foveal pit variations. Methods A Sloped Piecemeal Gaussian (SPG) model, consisting of a linear combination of a tilted line and a piecemeal Gaussian function (two halves of a Gaussian connected by a separate straight line), was developed to fit retinal thickness data with the flexibility to characterise different degrees of pit asymmetry and pit bottom flatness. It fitted the raw pit data between the two rims of the fovea to improve accuracy. The model was tested on 3488 macular scans from both eyes of 581 young adults (376 myopes and 206 non-myopes, mean (S.D.) age 21.9 (1.4) years). Estimates for retinal thickness, wall height and slope, pit depth and width were derived from the best-fitting model curve. Ten variations of Gaussian and Difference of Gaussian models were fitted to the same scans and compared with the SPG model for goodness of fit (by Root mean square error, RMSE), model complexity (by the Bayesian Information Criteria) and model fidelity. Results The SPG model produced excellent goodness of fit (mean RMSE = 4.25 and 3.89 μm; 95% CI: 4.20, 4.30 and 3.86, 3.93 for fitting horizontal and vertical profiles respectively). The SPG model showed pit asymmetry, with average nasal walls 17.6 (11.6) μm higher and 0.96 (0.61)° steeper than temporal walls and average superior walls 7.0 (12.2) μm higher and 0.41 (0.65)° steeper than the inferior walls. The SPG model also revealed a continuum of human foveal shapes, from round bottoms to extended flat bottoms (up to 563 μm). 49.1% of foveal profiles were best fitted with a flat bottom >30 μm wide. Compared with the other tested models, the SPG was the preferred model overall based on the Bayesian Information Criteria. Conclusions The SPG is a new parsimonious mathematical model that improves upon other models by accounting for wall asymmetry and flat pit bottoms, providing an excellent fit and more faithful characterisation of typical foveal pit shapes and their known variations. This new model may be helpful in distinguishing normal foveal shape variations by refractive status as well by other characteristics such as sex, ethnicity and age.

Objective Evaluate the effect of medications and medication changes during the Diabetes and Periodontal Therapy Trial (DPTT) on the primary study outcome, namely, change in hemoglobin A1c (HbA1c) at 6 months following baseline. Methods The DPTT set strict criteria for changes in diabetes medications. Medication change was defined as: change in dose of any 1 oral hypoglycemic agent by more than two-fold, change in dose of insulin of > 10% and/or addition or subtraction of an oral hypoglycemic agent, insulin or non-insulin injectable agents. Comparisons between the treatment (non- surgical periodontal therapy) and control (no therapy) groups used t-tests for continuous variables and chi-square tests for categorical variables, including DPTT defined diabetes medication changes between baseline (BL) and 3 month visits and 3- and 6-month visits. Changes in HbA1c were compared across the four medication change categories using ANOVA models, overall and for each treatment group separately. Results Baseline medication use was similar between the treatment groups (p > 0.40), as were medication changes between BL- 3 month visits and 3 and 6 month visits (p = 0.58). Participants with higher BL HbA1c (> 8%) and those taking insulin at BL were more likely to have a change in medication (p = 0.03). Conclusions The DPTT had the most rigorous definition of medication changes and medication monitoring of any trial in this field to date. The absence of a significant difference in medication changes between treatment groups may suggest that such changes did not play a role in the negative outcome of the DPTT.

Purpose: To describe longitudinal changes in corneal curvature (CC) and axial length (AL) over 14 years, and to explore the relationship between AL and CC, and the axial length/corneal radius (AL/CR) ratio. Methods: In total 469, 6 to

Loss to follow-up (LTFU) after anti-vascular endothelial growth factor (anti-VEGF) injections increases the risk of vision loss among patients with neovascular age-related macular degeneration (nAMD).To report rates of LTFU among patients with nAMD after anti-VEGF injections and to identify risk factors associated with LTFU in this population.This retrospective cohort study of data from 9007 patients who received anti-VEGF injections for treatment of nAMD was performed at an urban, private retina practice with multiple locations from April 1, 2012, to January 12, 2016.Rates of LTFU after anti-VEGF injections. Loss to follow-up was defined as receipt of 1 or more injections with no subsequent follow-up visit within 12 months.Among the 9007 patients (mean [SD] age, 81.2 [8.8] years; 5917 [65.7%] female; 7905 [87.8%] white), 2003 (22.2%) were LTFU. Odds of LTFU were greater among patients 81 to 85 years of age (odds ratio [OR], 1.58; 95% CI, 1.38-1.82; P .001), 86 to 90 years of age (OR, 2.29; 95% CI, 2.00-2.62; P .001), and more than 90 years of age (OR, 3.31; 95% CI, 2.83-3.86; P .001) compared with patients 80 years of age and younger. Odds of LTFU among African American patients (OR, 1.47; 95% CI, 1.00-2.16; P = .05), Asian patients (OR, 2.63; 95% CI, 1.71-4.03; P .001), patients of other race (OR, 3.07; 95% CI, 1.38-6.82; P = .006), and patients of unreported race (OR, 2.29; 95% CI, 1.96-2.68; P .001) were greater than odds of LTFU among white patients. Odds of LTFU were greater among patients with regional adjusted gross income of $50 000 or less (OR, 1.52; 95% CI, 1.30-1.79; P .001), $51 000 to $75 000 (OR, 1.35; 95% CI, 1.17-1.56; P .001), and $76 000 to $100 000 (OR, 1.28; 95% CI, 1.08-1.50; P = .004) compared with patients with incomes greater than $100 000. Odds of LTFU for patients living 21 to 30 miles (OR, 1.33; 95% CI, 1.05-1.69; P = .02) and more than 30 miles (OR, 1.55; 95% CI, 1.28-1.88; P .001) from clinic were greater compared with patients who lived 10 miles or less from the clinic. Odds of LTFU were greater among patients who received unilateral injections (OR, 1.44; 95% CI, 1.28-1.61; P .001) than among patients who received bilateral injections.We found a high rate of LTFU after anti-VEGF injections among patients with nAMD and identified multiple risk factors associated with LTFU among this population. Although our results may not be generalizable, data on LTFU in a clinical practice setting are needed to understand the scope of the problem so that interventions may be designed to improve outcomes.

To determine the rate of loss to follow-up (LTFU) and associated risk factors in patients with nonproliferative diabetic retinopathy (NPDR) who had diabetic macular edema (DME) and were receiving intravitreal anti-vascular endothelial growth factor (VEGF) injections.Retrospective cohort study.A total of 2595 NPDR patients with DME who received at least one anti-VEGF injection at a single large retina practice from January 1, 2012, to January 1, 2017.A retrospective review based on billing codes was performed. LTFU was defined as no subsequent office visits within 12 months after an intravitreal injection. Patient demographics and clinical features were evaluated, and logistic regression was used to identify independent predictors for LTFU.LTFU rates and potential risk factors.LTFU was found in 413 (25.3%) of 1632 patients. Examining LTFU by racial groups, 21.3% identified themselves as white, 29.1% as black, 30.6% as Asian, and 35.0% as Hispanic (P0.001). A difference in LTFU was also found based on average adjusted gross income (AGI) (P0.001) and NPDR stage (P = 0.04). In the multivariate model, factors associated with LTFU included Hispanic (odds ratio [OR] 1.66), American Indian, Pacific Islander, multiple races (OR 2.60), and unknown race (OR 1.59) compared with those who were white. Additional factors included those with an average AGI of $50000 to $75000 (OR 1.37) and$50000 (OR 1.88) compared with those with an average AGI$75000. Based on subgroup analysis of patients with available visual acuity data, a significant association was found between decreasing baseline vision and LTFU (P0.001).Approximately 1 in 4 patients with NPDR who had DME had no follow-up visit for at least 1 year after an anti-VEGF injection. Given the importance of ongoing therapy, these real-world findings may help identify at-risk groups for noncompliance with care.

To describe longitudinal changes in lens thickness in myopic children in the Correction of Myopia Evaluation Trial (COMET) and to investigate the association between these changes and myopia progression.Four-hundred sixty-nine 6 to12-year-old children with -1.25 to -4.50 D of myopia were enrolled in COMET, a clinical trial comparing single vision lenses (SVLs) versus progressive addition lenses (PALs) for slowing myopia. Children remained in their original lenses for 5 years and then could wear contact lenses, SVLs or PALs. Myopia by cycloplegic autorefraction (Nidek ARK 700A) and ocular components, including lens thickness, by A-scan ultrasound (Sonomed A2500) were measured annually over 11 years. Analyses of lens thickness were based on right eye data from 426 children with refractions fit with Gompertz functions. Longitudinal lens thickness measurements for each participant were fit with a third-degree polynomial function, and average polynomial functions were calculated for three groups of children previously identified based on Gompertz functions: 6-7 years at baseline (n = 40), ≥8 years with progressing myopia (n = 329), and ≥8 years with non-progressing myopia (n = 56). ANOVAs were used for comparing the lens curve-based parameters among the three groups. Associations between lens and Gompertz parameters were assessed using Pearson correlations.Overall, between 6 and 18 years the lenses thinned and then thickened, with the minimum value of 3.37 ± 0.15mm reached at 11.56 ± 2.04 years. The minimum lens thickness did not differ among the three myopia groups (p = 0.09), nor was it correlated with the amount of myopia at lens minimum or amount of final myopia (r's = -0.01 and -0.03, respectively, p's 0.05).As a similar pattern of change in lens thickness with age was found in all children, whether their myopia progressed or not, these results suggest that the association of lens thinning and thickening with the course of myopia is coincidental rather than causal.

Type 2 diabetes mellitus (T2DM) is a growing health problem worldwide. People with T2DM are at risk of experiencing periodontitis and likely require treatment. Using data from the national multicenter Diabetes and Periodontal Therapy Trial (DPTT), the authors assessed patient-based characteristics associated with the clinical response to nonsurgical therapy.The DPTT investigators randomly assigned adults with T2DM (hemoglobin A1c [HbA1c] ≥ 7 percent and9 percent) and moderate to advanced periodontitis to receive immediate or delayed therapy (scaling and root planing, oral hygiene instruction, chlorhexidine rinse). The investigators assessed probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and medical conditions at baseline, three months and six months. Six-month changes in mean PD, CAL and BOP defined the treatment response. Complete data were available for 473 of 514 DPTT participants. The authors used multiple regression models to evaluate participant-level factors associated with the response.More severe baseline PD, CAL and BOP were associated with greater improvements in these same measurements (P.0001). Hispanic participants experienced greater improvements in PD and CAL than did non-Hispanic participants (P.0001). Obese participants (those with a body mass index30 kilograms per square meter) experienced greater reductions in PD and BOP than did participants who were not obese (P.001). Age, sex, HbA1c values, diabetes duration, and smoking were not associated with change in any outcome (P.1).In patients with T2DM, baseline disease severity was associated with the clinical response to nonsurgical periodontal therapy. Body mass index and Hispanic ethnicity-but not glycemic control, diabetes duration or smoking-also may be useful in predicting clinical changes in this population.

To evaluate possible associations between primary open-angle glaucoma (POAG), dental health, and the oral microbiome. Case-control study was conducted at SUNY Downstate. Adult subjects (40 to 87 y) were recruited as POAG cases (n=119) and controls without glaucoma (n=78) based on visual field and optic nerve criteria. Overall 74.6% were African Americans (AA). Information on medical history and oral health was collected and ophthalmologic examinations were performed. Mouthwash specimens (28 AA cases and 17 controls) were analyzed for bacterial DNA amounts. Analyses were limited to AAs as the predominant racial group. Outcome measures included number of natural teeth, self-reported periodontal health parameters, and amounts and prevalence of oral bacterial species. Logistic regression was used to evaluate associated factors and potential interactions. Cases and controls had similar age (mean: 62.2 and 60.9 y, respectively, P>0.48), and frequency of hypertension, diabetes, but cases had a higher proportion of men (P

PURPOSE To examine internal astigmatism (IA) in myopes and non-myopes using a new method to assess compensation of corneal astigmatism (CA) by IA, to look for predictors of high IA in young adult myopes, and to determine if as CA changes IA changes to reduce refractive astigmatism (RA) in an active compensatory process in myopes. METHODS Right eye keratometry and cycloplegic autorefraction were measured annually over 14 years in 367 myopes and once in 204 non-myopes age- (mean 21.91 ± 1.47 years), gender-, and ethnicity-matched to myopes at year 12. CA and RA at the corneal plane were expressed as J0, J45. IA = RA - CA. Inverse power transformation provided cylinder power and axis of IA for the compensation factor (IA/CA). Analyses included (1) paired and unpaired t-tests (refractive data), (2) chi-square tests (distributions of compensation factor), (3) logistic regression analysis (predictors of high IA), and (4) linear mixed models (time effect on RA, CA, and IA). RESULTS The magnitude of IAJ0 varied by refractive error (myopes -0.25 ± 0.24 vs. non-myopes -0.32 ± 0.21, p < 0.001). Compensation of CA by IA was poorer in myopes than non-myopes (χ p < 0.001). When matched by CA, compensation remained poorer in myopes than non-myopes (χ all p ≤ 0.04). Within each refractive group, compensation was better when CA was low than high (χ p < 0.001). When CA was low in myopes, high IA (≥1.00D) was less likely (p = 0.01). Longitudinal follow-up of myopes found no evidence for an active compensatory role for IA as CA increased over time. There were differences in IAJ0 by ethnicity over time (p < 0.0001). CONCLUSIONS In myopic and non-myopic eyes with low amounts of CA, IA may reduce CA's contribution to RA, but IA is not a constant. However, there is no evidence for an active compensatory role for IA reducing CA in myopes.

Myopia is a risk factor for glaucoma, retinal detachments, and degenerative changes in the central retina, conditions which can lead to significant vision loss.1, 2 Because the prevalence of myopia is increasing, the economic and visual burden of these related diseases may also increase.3 It is therefore important to understand why the myopic eye seems to be more susceptible to disease. Some previous studies have utilized more traditional examination methods, such as binocular indirect ophthalmoscopy.4–6 However, retinal structures can now be visualized in vivo using optical coherence tomography (OCT). 7 The resolution of commercially available OCT systems is approximately 5 to 10 microns, allowing visualization of distinct layers within the retina.8 This technology allows more sensitive and standardized measures of the retina in the living eye, which should enhance our understanding of the pathophysiology of myopia and its relationship to the development of other ocular diseases. Previous OCT studies have suggested that macular thickness is associated with age, gender, ethnicity, axial length, and refractive error.9–21 These studies have used different instruments and algorithms and include populations that differ by age, gender, ethnicity, country of origin, and refractive status. Despite these differences, most 10,11,15–18 but not all 9,14 studies report that females have thinner maculas than males. In addition, persons of African descent have thinner central foveas and some quadrants of the outer foveal regions compared to other ethnic groups, with some variation among studies.9–15 Some OCT studies, mainly performed in Asia, have explored the potential relationship between macular thickness and axial length and/or amount of myopia.15–21 In these studies, increased axial length has been associated with thicker central foveas17–20 and some thinner quadrants in the para- and peri-foveal regions, 16–20 with one study finding no association.15 Results for refractive error are more mixed; some studies find that myopia is associated with a thicker central fovea and some thinner para- and peri-foveal quadrants, 18–21 while others find no association.15–17 No prior studies have included large numbers of myopic young adults of different ethnic backgrounds. Data from the Correction of Myopia Evaluation Trial (COMET) allow the investigation of macular thickness and related factors in a large, multi-ethnic group who were aged 6–11 years with low to moderate myopia when they enrolled in COMET in 1997 and aged 17–22 years at the time of OCT measurements, 11 years later. The purpose of this study is to determine whether macular thickness is related to ethnicity, gender, axial length and amount of myopia in a large cohort of myopic young adults, in which over one-quarter have high myopia (worse than –6.0 D). These data should enhance our understanding of factors associated with macular thickness in individuals with myopia, which has increased in prevalence in recent years to 40% of the population aged 12–54 years living in the United States.3

Purpose: To evaluate: (i) the relationship between intraocular pressure (IOP) reduction attained with a fixed treatment protocol and the untreated IOP level; (ii) the consistency of IOP reduction over time; and (iii) whether there is a threshold pretreatment IOP level below which IOP reduction might be less effective. Results are based on 128 patients with glaucoma with field defects, who were randomized to the treatment arm of the Early Manifest Glaucoma Trial (EMGT). Methods: The EMGT fixed treatment protocol consisted of 360 degrees laser trabeculoplasty and topical betaxolol eye drops B.I.D. Treatment was unchanged as long as progression did not occur. Analyses assessed the initial IOP reduction after 3 months and also the mean reduction based on all follow-up values; IOP changes over time were evaluated with linear regression analysis. Factors influencing initial and mean IOP reduction were also explored using linear models. Results: Mean age at baseline was 68 years, and untreated baseline IOP ranged from 13 to 30.5 mmHg. On average, eyes with higher baseline IOP experienced larger pressure reductions than eyes with lower baseline IOP, whether expressed in mmHg or as percentages. Each mmHg of higher baseline IOP was associated with approximately 0.6 mmHg larger IOP reduction. IOP changed little over time, with 66% of patients changing less than 0.5 mmHg/year, and only 13% (17/128) changing >1.0 mmHg/year. The treatment protocol did not achieve any average IOP reduction in eyes with baseline pressures

OBJECTIVE: This article, based on the Early Manifest Glaucoma Trial (EMGT), provides prospective natural history data on progression of glaucomatous field defects in 3 of the most common glaucoma types. DESIGN: Cohort of EMGT patients randomized to the untreated control group and followed up to the time of progression, when treatment could be initiated. PARTICIPANTS: We evaluated 118 control patients: 46 with high-tension glaucoma (HTG), 57 with normal-tension glaucoma (NTG), and 15 with pseudoexfoliation glaucoma (PEXG). METHODS: Visual fields were tested every 3 months with the Humphrey 30-2 Full Threshold test program. MAIN OUTCOME MEASURES: Linear regression analyses of the perimetric mean deviation (MD) values were performed, and the rate of progression was defined as the regression coefficient in decibels per year. Percentages of progressed eyes and time to progression were determined using EMGT event-based predetermined progression criteria derived from Glaucoma Change Probability Maps. RESULTS: The median and interquartile rates of visual function loss were -0.40 (1.05) dB/year overall and -0.46 (1.61) in HTG, -0.22 (0.65) in NTG, and -1.13 (6.13) in PEXG. Thus, interpatient variability was large. Mean rates were considerably higher than medians: -1.08 dB/year overall, -1.31 in HTG, -0.36 in NTG, and -3.13 in PEXG. Differences in median visual function progression rates among groups were statistically significant (NTG vs. HTG, P = 0.003; PEXG vs. non-PEXG, P

PURPOSE: Three major glaucoma trials, all using the same Humphrey visual field tests, specified different criteria to define visual field progression. This article compares the performance of these criteria with a reference standard of unanimous classifications by 3 independent glaucoma experts. DESIGN: Longitudinal, comparative study of diagnostic criteria. PARTICIPANTS AND CONTROLS: Two hundred forty-five patients with manifest glaucoma in the Early Manifest Glaucoma Trial (EMGT). METHODS: Visual field series of 1 eye of each of 245 EMGT patients were classified by 3 independent glaucoma specialists as definitely progressing, definitely nonprogressing, or neither. Field series that were classified in the first 2 categories by all 3 experts met the reference standards for the progressing and nonprogressing groups and were analyzed according to the progression criteria of the Advanced Glaucoma Intervention Study (AGIS), the Collaborative Initial Glaucoma Treatment Study (CIGTS), and the EMGT. Sensitivity, specificity, time to progression, and sustainability were calculated. MAIN OUTCOME MEASURES: Progression, nonprogression, sensitivity, specificity, time to progression, and sustainability. RESULTS: Seventy-seven field series were definitely progressing, and 95 series were definitely nonprogressing. Among progressing eyes, 45 (58%) of 77 were identified using AGIS criteria, 58 (75%) of 77 were identified with CIGTS criteria, and 74 (96%) of 77 were identified with EMGT criteria; all comparisons of sensitivities were significant, simultaneous (P

Purpose: To determine progression factors at the end of the Early Manifest Glaucoma Trial (EMGT) based on all EMGT patients and evaluate separately patients with higher and lower baseline intraocular pressure (IOP; median split). Design: Cohort of clinical trial participants. Participants: Patients with early open-angle glaucoma randomized to argon laser trabeculoplasty plus betaxolol (n = 129) or no immediate treatment (n = 126), examined every 3 months for up to 11 years. Methods: Cox proportional hazard analyses, expressed by hazard ratios (HRs) and 95% confidence intervals (Cls). Main Outcome Measure: Time to progression, defined by perimetric and photographic disc criteria. Results: Overall progression was 67% when follow-up ended (median, 8 years). Treatment approximately halved progression risk (HR, 0.53; 95% Cl, 0.39-0.72); results were similar for patients with higher and lower baseline IOP (HRs, 0.41 and 0.55). Baseline progression factors (HRs, 1.51-2.12; P

To examine the relationship of choroidal thickness with axial length (AL) and myopia in young adult eyes in the ethnically diverse Correction of Myopia Evaluation Trial (COMET) cohort.Cross-sectional, multicenter study.In addition to measures of myopia by cycloplegic autorefraction and AL by A-scan ultrasonography, participants underwent optical coherence tomography imaging of the choroid in both eyes at their last visit (14 years after baseline). Using digital calipers, 2 independent readers measured choroidal thickness in the right eye (left eye if poor quality; n = 37) at 7 locations: fovea and 750, 1500, and 2250 μm nasal (N) and temporal (T) to the fovea.Choroidal thickness measurements were available from 294 of 346 (85%) imaged participants (mean age: 24.3 ± 1.4 years; 44.9% male) with mean myopia of -5.3 ± 2.0 diopters and mean AL of 25.5 ± 1.0 mm. Overall, choroidal thickness varied by location (P.0001) and was thickest at the fovea (273.8 ± 70.9 μm) and thinnest nasally (N2250, 191.5 ± 69.3 μm). Multivariable analyses showed significantly thinner choroids in eyes with more myopia and longer AL at all locations except T2250 (P ≤ .001) and presence of peripapillary crescent at all locations except T1500 and T2250 (P ≤ .0001). Choroidal thickness varied by ethnicity at N2250 (P.0001), with Asians having the thinnest and African Americans the thickest choroids.Choroids are thinner in longer, more myopic young adult eyes. The thinning was most prominent nasally and in eyes with a crescent. In the furthest nasal location, ethnicity was associated with choroidal thickness. The findings suggest that choroidal thickness should be evaluated, especially in the nasal regions where myopic degenerations are most commonly seen clinically.

To provide 9-year incidence estimates of age-related macular degeneration (AMD) in a population of African descent.Population-based cohort study.Two thousand seven hundred ninety-three participants (81% of eligible) after 9 years' follow-up.Nine-year incidence of AMD-related features, based on fundus photographic gradings and/or clinical examinations.The overall incidence rate of early AMD was 12.6% (95% confidence interval [CI], 11.0%-14.1%), and that of late AMD was 0.7% (95% CI, 0.4%-1.1%). Both increased with age (P0.05). For early AMD, incidence ranged from 10.7% at 40 to 49 years of age to 16.8% ator =70 years. For late AMD, incidence increased from 0.1% to 2.3% in the same age groups. Late AMD was more likely to develop in eyes with pigment changes (risk ratio [RR], 5.8; 95% CI, 2.0-16.8) and retinal pigment epithelial atrophy (RR, 5.4; 95% CI, 1.9-15.8) at baseline. Crude RRs indicated significant associations of late AMD to elevated systolic blood pressure and diabetes history, but only the diabetes relationship was suggested after adjusting for age, with borderline statistical significance (age-adjusted RR, 2.7; P = 0.054).Nine-year data on natural history indicate that early AMD is common in this population of African origin, although late AMD is infrequent. These long-term observations provide further evidence for the lower AMD risk in black populations compared with white populations.

Background The Correction of Myopia Evaluation Trial (COMET), a randomized, multicenter clinical trial of myopia progression in children, had an exceptionally high retention rate of 98.5% (462/469) at three years of follow-up. The present investigation was designed to evaluate and compare the reasons for COMET's high retention rate according to participating families and clinical center staff. Methods Families ( n = 411) and staff ( n = 35) completed a confidential 19-item questionnaire by indicating families' levels of preference for each item, and rating its importance in keeping families in the study. The questionnaire evaluated study features in four categories: staff characteristics, operational aspects, specific study elements, and incentives. Results Results showed that most families viewed the study very favorably. Features that appealed to 90% or more families and promoted continued study participation included staff attributes such as friendliness, responsiveness and encouragement, and aspects pertaining to standard of care such as completeness of eye exam, quality of eye care and free eyeglasses. Compared to families, staff tended to underestimate the importance of the following features for retention: seeing the same staff at each visit, appointment reminders, center location, newsletters, commitment to the study, being part of a nationwide study, length of the study, association with a college of optometry, completeness of eye exam, and eye drops ( p < 0.05 by chi-square analyses). However, staff responses also revealed less preferred components of the study protocol (e.g., eye drops), to which families might have been reluctant to respond unfavorably. Conclusions Our findings highlight the importance of intangible factors such as staff attributes and participants' study commitment in maintaining high retention rates, and the usefulness of surveying both families and staff.

To evaluate the effect of treatment, visual function, and other factors on vision-targeted health-related quality of life (HRQOL) of patients with early glaucoma.Randomized clinical trial.Two hundred fifty-five patients with newly detected open-angle glaucoma and repeatable early visual field (VF) defects, 50 to 80 years old (66% female).Patients were randomized to receive either betaxolol plus laser trabeculoplasty in eligible eye(s) or no initial treatment and had ophthalmologic examinations every 3 months. A Swedish translation of the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was self-administered at 2 follow-up visits (3 and 6 years after randomization).Multiple linear regression analyses determined the effect of treatment and other factors on (1) VFQ-25 composite scores at the first administration and (2) change in scores between administrations.Two hundred thirty-three patients had 1 NEI VFQ-25 administration and 167 patients had 2 administrations. Internal consistency reliability was high for the composite VFQ-25 score (Cronbach alpha = 0.88) and satisfactory (alphaor =0.76) for most subscale scores. At the first administration, the composite score was high (88.8+/-11.7). Mean subscale scores were also generally high (98.0-58.3) and were similar for each study group when analyzed separately. Most lower subscale scores were modestly but significantly related to worse visual acuity (VA) or mean deviation (MD) (better eye, r = 0.15-0.35). Composite scores were similar for treated and untreated patients. Lower composite scores were associated with low VA in the better eye (worse than 0.70) and worse perimetric MD (4.16 decibels) and nuclear lens opacities (Lens Opacities Classification System II gradeor = 2), but not with age, gender, VF progression, intraocular pressure, cardiovascular disease, or hypertension. Between VFQ-25 administrations, larger decreases in the composite score were associated with larger decreases in VA (P0.05), female gender (P = 0.001), and older age at first administration (P = 0.006). Treatment (assigned at randomization or later in the study) was not associated with change in HRQOL.Results suggest that absence or delay of treatment did not influence vision-targeted HRQOL in these newly diagnosed glaucoma patients. However, visual function affected vision-targeted quality of life up to 6 years after Early Manifest Glaucoma Trial enrollment.

Objectives To evaluate factors related to the incidence of diabetic retinopathy (DR) in a population of African descent, after 9 years of follow-up. Design Population-based cohort study; 81% participation after 9 years. Participants Three hundred twenty-four participants of the Barbados Eye Studies, with diabetes mellitus (DM) at baseline and at risk for developing DR during follow-up. Methods Diabetes-related changes were assessed by masked gradings of baseline and follow-up photographs using a standardized system. The 9-year cumulative incidence of DR was based on participants with DM and free of retinopathy at baseline; incidence rates were estimated by the product-limit approach. Cox regression models for discrete-time data were used to evaluate risk factors associated with the 9-year incidence of DR. Results Multivariate analyses revealed that older age at DM onset decreased the 9-year risk of DR development; for each 10 years of older age at onset, the risk of DR decreased by 30% (risk ratio [RR], 0.7; 95% confidence interval [CI], 0.56–0.96). The risk of DR doubled among persons with DM duration between 5 and 9 years (RR, 2.1; 95% CI, 1.2–3.6) versus those with shorter durations; it also doubled in those treated with oral medications or insulin at baseline versus those treated with diet only. Antihypertensive treatment halved the risk of DR versus no treatment (RR, 0.5; 95% CI, 0.3–0.9) and high systolic or diastolic blood pressure (BP) increased risk. Thus, DR risk increased by 30% for every 10 mmHg of higher systolic BP at baseline (RR, 1.3; 95% CI, 1.1–1.4) or of BP increase from baseline to the 4-year follow-up (RR, 1.3; 95% CI, 1.1–1.4). Diabetic retinopathy risk similarly increased with each 1% of higher glycosylated hemoglobin level at baseline (RR, 1.3; 95% CI, 1.2–1.5). Conclusions The long-term follow-up of persons with DM in this population of African origin, where disease prevalence is high, identified important potentially modifiable risk factors for DR. Findings suggest that efforts to achieve optimal glycemic and BP control may reduce the vision-threatening complications of DM.

Healthy control participants (46 women, M age = 44.3 yr., SD = 7.6; 29 men) were recruited to undergo a comprehensive neuropsychological battery and serve as a comparison group in a study of cognitive functioning in patients with Lyme disease. Participants were selected using Mitofsky-Waksberg random digit dialing. The Buschke 12-word, six-trial Selective Reminding Test was administered as part of the neuropsychological battery and normative data are presented stratified by age and sex. Performance on alternate forms of this measure were examined. Mean education, intelligence quotient, and Wide Range Achievement Test-3 Reading scores are reported.

PURPOSE To evaluate self-esteem and its relationship with various ocular and demographic characteristics in 469 myopic children participating in the Correction of Myopia Evaluation Trial (COMET), an ongoing, randomized, multicenter clinical trial designed to evaluate the effects of progressive addition lenses vs. single vision lenses on the progression of juvenile-onset myopia. METHODS Baseline data collection included demographic information, refractive error measurements, parent-reported myopia history, child-reported visual symptoms, and self-esteem in several areas (scholastic/athletic competence, physical appearance, social acceptance, behavioral conduct, and global self-worth) as measured by the Self-Perception Profile for Children. Univariate and multiple regression analyses were used to identify factors associated with self-esteem. RESULTS The Self-Perception Profile for Children is a reliable measure of self-esteem in COMET children as indicated by the high internal consistency reliabilities (0.74 to 0.81) obtained for the various domains. COMET children's mean self-esteem scores ranged from 2.72 +/- 0.69 for athletic competence to 3.36 +/- 0.56 for global self-worth and were similar to normative samples. Multiple regression analyses showed that less symptomatic children had higher self-esteem in all areas (p < 0.05), except athletic competence, after adjusting for other ocular and demographic characteristics. Self-esteem also varied significantly by age, gender, and ethnicity (p < 0.05). CONCLUSIONS Baseline self-esteem is associated with visual symptoms, age, gender, and ethnicity, but not with magnitude of refractive error. Follow-up reports will assess whether there are changes in self-esteem associated with myopia progression and lens assignment.

Background Glaucoma is a progressive optic nerve degenerative disease that often leads to blindness. Local inflammatory responses are implicated in the pathology of glaucoma. Although inflammatory episodes outside the CNS, such as those due to acute systemic infections, have been linked to central neurodegeneration, they do not appear to be relevant to glaucoma. Based on clinical observations, we hypothesized that chronic subclinical peripheral inflammation contributes to neurodegeneration in glaucoma. Methods Mouthwash specimens from patients with glaucoma and control subjects were analyzed for the amount of bacteria. To determine a possible pathogenic mechanism, low-dose subcutaneous lipopolysaccharide (LPS) was administered in two separate animal models of glaucoma. Glaucomatous neurodegeneration was assessed in the retina and optic nerve two months later. Changes in gene expression of toll-like receptor 4 (TLR4) signaling pathway and complement as well as changes in microglial numbers and morphology were analyzed in the retina and optic nerve. The effect of pharmacologic blockade of TLR4 with naloxone was determined. Findings Patients with glaucoma had higher bacterial oral counts compared to control subjects (p

To use the Gompertz function to estimate the age and the amount of myopia at stabilization and to evaluate associated factors in the Correction of Myopia Evaluation Trial (COMET) cohort, a large ethnically diverse group of myopic children.The COMET enrolled 469 ethnically diverse children aged 6 to younger than 12 years with spherical equivalent refraction between -1.25 and -4.50 diopters (D). Noncycloplegic refraction was measured semiannually for 4 years and annually thereafter. Right eye data were fit to individual Gompertz functions in participants with at least 6 years of follow-up and at least seven refraction measurements over 11 years. Function parameters were estimated using a nonlinear least squares procedure. Associated factors were evaluated using linear regression.In total, 426 participants (91%) had valid Gompertz curve fits. The mean (SD) age at myopia stabilization was 15.61 (4.17) years, and the mean (SD) amount of myopia at stabilization was -4.87 (2.01) D. Ethnicity (P0.0001) but not sex or the number of myopic parents was associated with the age at stabilization. Ethnicity (P = 0.02) and the number of myopic parents (P = 0.01) but not sex were associated with myopia magnitude at stabilization. At stabilization, African Americans were youngest (mean age, 13.82 years) and had the least myopia (mean, -4.36 D). Participants with two versus no myopic parents had approximately 1.00 D more myopia at stabilization. The age and the amount of myopia at stabilization were correlated (r = -0.60, P0.0001).The Gompertz function provides estimates of the age and the amount of myopia at stabilization in an ethnically diverse cohort. These findings should provide guidance on the time course of myopia and on decisions regarding the type and timing of interventions.

Purpose To evaluate the association between outdoor and nearwork activities at baseline and myopia stabilisation by age 15 in the Correction of Myopia Evaluation Trial (COMET). Methods Correction of Myopia Evaluation Trial enrolled 469 children (ages: 6–11 years) with spherical equivalent myopia between −1.25 and −4.50 D, who were randomised to progressive addition or single vision lenses and followed for 5 years in their original lenses. At baseline, families recorded the child's outdoor and nearwork activities for 3 days within a week. Weekly hours spent in nearwork and outdoor activities were calculated for each participant. Refractions collected over 11 years were fit using the Gompertz function to determine each participant's myopia stabilisation age. Myopia for each child was then categorized as stable/not stable by age 15. Results Half (233/469) of participants had usable baseline activity diaries and refraction data that could be fit with the Gompertz function, 59.7% (139/233) had stable myopia by age 15 and 40.3% had myopia that was not yet stable. The frequency of stable myopia was similar for the two categories (median split) of outdoor activities: 60% (71/118) for ≤9.0 hours/week−1 and 59% (68/115) for >9.0 hours/week−1. 56% (64/114) of children reporting >21.0 h of baseline weekly nearwork activity had stable myopia by age 15 compared to 63% (75/119) with ≤21.0 h of near work (adjusted OR = 0.74; 95% CI: 0.43–1.29). Using baseline nearwork as a continuous variable, the multivariable odds ratio for the association between baseline nearwork hours and stabilisation by age 15 is 0.98: 95% CI: 0.96–1.00, a result trending towards significance. Conclusion While time spent in outdoor activities in childhood does not appear to be related to myopia stabilisation by age 15, less near work activity might potentially be associated with myopia stabilisation by that age.

Objectives: To characterize intraocular pressure (IOP) changes during 6 years of follow-up among patients with early, newly diagnosed glaucoma randomized to no initial treatment in the Early Manifest Glaucoma Trial (control group) and to evaluate factors associated with IOP changes in this group. Methods: Early Manifest Glaucoma Trial control patients, aged 50 to 80 years at baseline, were followed up for 6 years or to the time of progression, when treatment could be initiated. After baseline, patients were followed up every 3 months with comprehensive ophthalmologic examinations, including Goldmann applanation tonometry. Change in IOP over 6 years was assessed by linear regression analyses. Results: At baseline, the median IOP of this cohort (N = 118) was 20.8 mm Hg and was higher for the 15 patients with exfoliation glaucoma (24.0 mm Hg vs 20.0 mm Hg for others; P = .005). In patients without exfoliation glaucoma, IOP remained stable during follow-up (median IOP change of -0.01 mm Hg/y; interquartile range, 0.85 mm Hg/y). In comparison, patients with exfoliation glaucoma showed a significantly larger median change of 0.96 mm Hg/y (interquartile range, 3.11 mm Hg/y) (P = .004). In the overall cohort, the only factor related to IOP change was exfoliation glaucoma (P < .001). Among patients without exfoliation glaucoma, no factors were associated with IOP change. Conclusions: In patients with early glaucoma, IOP remained stable without treatment during a 6-year period, regardless of baseline IOP, except for patients with exfoliation glaucoma, where IOP increased by almost 1 mm Hg annually. No factors, aside from exfoliation glaucoma, were related to longitudinal changes in IOP. These new natural history data may be useful in guiding management decisions for glaucoma treatment, particularly in patients with early disease or with exfoliation glaucoma. (Less)

Indications and surgical techniques for penetrating keratoplasties (PKs) were evaluated to determine present trends and suggest future directions for PK. Analyses were based on 3,941 PK cases, with questionnaires completed at the time of surgery by 638 surgeons receiving tissue through Tissue Banks International, Inc. between July 1, 1985, and December 31, 1988. The leading indications for PK were pseudophakic corneal edema (PCE) (23%), graft failure (17%), Fuchs' corneal dystrophy (13%), kerataconus (13%), keratitis/scar (12%), and aphakic corneal edema (10%). Indications for PK varied by age and sex. Anterior chamber (AC) lenses accounted for the majority (56%) of PCE cases. Penetrating keratoplasty for PCE occurred within 5 years of cataract surgery for 81% of patients with PC lenses and only 52% of patients with AC lenses. Intraocular lens exchange was performed in most AC and iris-fixed lens PCE cases (65% and 77%, respectively), but less frequently in PC lens cases (17%). A PC lens was placed in 29% of all PCE lens exchange cases. These data have confirmed and expanded observations from smaller studies about leading indications and surgical techniques for PK. Therefore, eye bank data may be useful in describing and monitoring future indications and trends for PK because they provide a broader base of information than that obtained through a single institution.

To describe the 9-year incidence of visual impairment and primary causes of blindness among black participants of the Barbados Eye Studies (BES).Population-based prospective cohort study.The BES followed a nationally representative cohort selected by simple random sampling, aged 40 to 84 years at baseline, with reexaminations after 4 years (Barbados Incidence Study of Eye Diseases [BISED]) and 9 years (BISED II). BISED II included 2793 (81%) of those eligible.Cumulative 9-year incidence rates were estimated by the Product-Limit approach. The study was reviewed and approved by the institutional review boards of collaborating institutions.Best-corrected visual acuity (VA) was assessed by the Ferris-Bailey chart, following a modified Early Treatment of Diabetic Retinopathy Study protocol. Low vision and blindness were defined by World Health Organization (WHO) criteria as VA6/18 to 6/120, and6/120, respectively, in the better eye, and by U.S. criteria as VAor =20/40 andor =20/200, respectively. Vision loss was defined as a decrease of 15 letters or more read correctly in the better eye between baseline and follow-up examinations.The 9-year incidence was 1.0% and 2.1% for blindness and 6.0% and 9.0% for low vision, by WHO and U.S. criteria, respectively. Older age at baseline was associated with higher incidence of low vision and blindness, reaching 23.0% (95% confidence interval [CI], 18.8-28.0) and 4.3% (95% CI, 2.7-6.9) at age 70 years or more, based on WHO criteria. The primary causes of incident bilateral blindness (U.S. criteria) in 126 eyes were age-related cataract (48.3%), open-angle glaucoma (OAG) (14.3%), combined cataract and OAG (6.3%), diabetic retinopathy (8.7%), and optic atrophy (7.1%). Age-related macular degeneration (2.4%) rarely caused blindness.Incident visual impairment is exceedingly high in this population. Cataract, OAG, and diabetic retinopathy remain the major causes of blindness, underpinning the clinical and public health significance of these conditions in this and similar populations.

To evaluate two clinical procedures, Monocular Estimate Method (MEM) and Nott retinoscopy, for detecting accommodative lags 1.00 diopter (D) or greater in children as identified by an open-field autorefractor.One hundred sixty-eight children 8 to12 years old with low myopia, normal visual acuity, and no strabismus participated as part of an ancillary study within the screening process for a randomized trial. Accommodative response to a 3.00 D demand was first assessed by MEM and Nott retinoscopy, viewing binocularly with spherocylindrical refractive error corrected, with testing order randomized and each performed by a different masked examiner. The response was then determined viewing monocularly with spherical equivalent refractive error corrected, using an open-field autorefractor, which was the gold standard used for eligibility for the clinical trial. Sensitivity and specificity for accommodative lags of 1.00 D or more were calculated for each retinoscopy method compared to the autorefractor.One hundred sixteen (69%) of the 168 children had accommodative lag of 1.00 D or more by autorefraction. MEM identified 66 children identified by autorefraction for a sensitivity of 57% (95% CI = 47 to 66%) and a specificity of 63% (95% CI = 49 to 76%). Nott retinoscopy identified 35 children for a sensitivity of 30% (95% CI = 22 to 39%) and a specificity of 81% (95% CI = 67 to 90%). Analysis of receiver operating characteristic curves constructed for MEM and for Nott retinoscopy failed to reveal alternate cut points that would improve the combination of sensitivity and specificity for identifying accommodative lagor =1.00 D as defined by autorefraction.Neither MEM nor Nott retinoscopy provided adequate sensitivity and specificity to identify myopic children with accommodative lagor =1.00 D as determined by autorefraction. A variety of methodological differences between the techniques may contribute to the modest to poor agreement.

To evaluate factors associated with the development of high myopia (worse than -6.00 D) over 7 years of follow-up in the COMET cohort.COMET enrolled 469 ethnically diverse children (6-11 years) with myopia between -1.25 and -4.50 D. They were randomized to either progressive addition lenses (PALs) or single vision lenses (SVLs), and followed for 5 years in their original lens assignment and 2 additional years wearing either spectacles (PALs or SVLs) or contact lenses. Refractive error was measured annually by cycloplegic autorefraction and axial length by A-Scan ultrasonography. Myopia for each child was defined as the mean spherical equivalent refractive error (SER) of the 2 eyes. Analyses were based on 7 years of follow-up. Time to high myopia was analyzed by Cox proportional hazard models and linear regression. Parental refraction data were available from 240 COMET subjects.Younger (6-7 years) versus older (11 years) age at baseline was a significant risk factor (adjusted hazard ratio (HR) = 6.6, 95% CI = 3.4, 12.7) for having high myopia within 7 years. More (SER from -2.26 to -4.50 D) vs. less (SER from -1.25 to -2.25 D) baseline myopia was also a significant risk factor for high myopia at 7 years (adjusted HR = 7.4, 95% CI = 4.4, 12.4). Gender, ethnicity, and treatment assignment were not associated with the risk of high myopia within 7 years. Increased number of myopic parents was associated with a significant risk of high myopia in the children (p = 0.008).Children who developed high myopia during 7 years of follow-up were younger and had more myopia at baseline. They also were more likely to have two myopic parents. These children may be at greater risk for sight-threatening conditions later in life.

PURPOSE The present study investigated the relationship between parental refractive error and myopia progression in their offspring and the interaction between parental ametropia and the effects of wearing progressive-addition (PALs) or single-vision (SVLs) lenses on the progression of myopia in children enrolled in the Correction of Myopia Evaluation Trial (COMET). METHODS The progression of myopia in a subset of COMET children (N= 232; 49% of initial group) was defined as the difference in mean spherical equivalent refraction of both eyes obtained by cycloplegic autorefraction between the baseline and 5-year visit. Parental refractions were obtained by noncycloplegic autorefraction (81%) or from recent eye examination records (19%). RESULTS The number of myopic parents (mean spherical equivalent refraction

Objective To determine the effectiveness of treatment with conjugated equine estrogens (CEE) or with CEE combined with progestin (CEE + P) on age-related macular degeneration (AMD). Methods In an ancillary study to the Women's Health Initiative clinical trial of hormone therapy, 4262 women 65 years and older underwent fundus photography for the determination of AMD. Participants were recruited from April 2000 to June 2002 at 21 clinical sites an average of 5 years after randomization. Participants were randomized to treatment with CEE, CEE + P, or placebo. Participants had been treated for an average of 5 years at the ophthalmic evaluation for AMD. Results The overall prevalence of any AMD was 21.0%. No association was found between CEE + P (odds ratio [OR], 0.91; 95% confidence interval [CI], 0.75-1.11) or CEE alone (OR, 0.98; 95% CI, 0.78-1.25) and early-stage AMD. The CEE + P was associated with a reduced risk of soft drusen (OR, 0.83; 95% CI, 0.68-1.00) after adjustment for covariates and with a reduced risk of neovascular AMD (OR, 0.29; 95% CI, 0.09-0.92). Conclusions Treatment with CEE alone or CEE + P does not affect early- or late-stage AMD. Treatment with CEE + P may reduce the risk of soft drusen or neovascular AMD.

Purpose To determine the 9-year incidence of open-angle glaucoma (OAG) in African-descent participants of the Barbados Eye Studies. Design Nine-year cohort study with 81% to 85% participation. Participants Three thousand two hundred twenty-two persons without definite OAG at baseline, at risk of developing OAG at follow-up. Methods The standardized protocol included automated perimetry and various ophthalmic measurements, with a comprehensive ophthalmologic examination for those referred. Fundus photographs were evaluated independently by masked graders. Incidence was estimated by the product-limit approach. Relative risk (RR) ratios with 95% confidence intervals (CIs) were based on Cox regression models with discrete time. Main Outcome Measure Nine-year incidence of definite OAG, based on the development of visual field defects and glaucomatous optic neuropathy, with ophthalmologic confirmation. Results The 9-year incidence of definite OAG was 4.4% (95% CI, 3.7%–5.2%), or an average of 0.5%/year, based on 125 new cases. Incidence increased greatly with age, from 2.2% at ages 40 to 49 years to 7.9% at ages 70 years or older, and tended to be higher in men than women (4.9% vs. 4.1%; RR, 1.3; 95% CI, 0.9–1.8). More than half (53%) of new cases were undetected, and of these, one third had intraocular pressure of 21 mmHg or less. When 141 persons developing suspected/probable OAG were considered, the total incidence was 9.4% (8.4%–10.6%), averaging approximately 1%/year, also increasing with age, and significantly higher in men than women (10.7% vs. 8.6%; RR, 1.31; 95% CI, 1.02–1.67). Conclusions These new data provide a measure of the long-term risk of OAG in an African-descent population, which is markedly higher than in persons of European ancestry. Results confirm the increased risk with age and in men. The incidence data fill a gap in our understanding of OAG risk and have implications for public health policy and planning; they also will allow the study of factors related to the risk of OAG development.

Objective To identify the baseline factors independently related to 3-year myopia progression and axial elongation in COMET. Methods A total of 469 children were enrolled, randomly assigned to progressive addition lenses with a + 2.00 diopter (D) addition or to single vision lenses and observed for 3 years. Eligible children were 6 to 11 years old, with spherical equivalent myopia of − 1.25 to − 4.50 D, bilaterally. The primary and secondary outcomes, myopia progression by cycloplegic autorefraction and axial elongation by A-scan ultrasonography, were measured annually. Multiple linear regression was used to adjust for covariates, including treatment. Results Younger baseline age (6-7 vs 11 years, 8 vs 11 years, and 9 vs 11 years, P P = .04), female sex ( P = .01), and each ethnic group compared with African Americans (Asian, P = .02; Hispanic, P = .002; mixed, P = .002; white, P = .001) were independently associated with faster 3-year progression. Children aged 6 to 7 years had the fastest progression of all age groups, progressing by a mean (± SD) of 1.31 D ± 0.13 more than children aged 11 years. Females progressed 0.16 D more than the males. Children of mixed, Hispanic, Asian, and white ethnicity progressed more than African American children by 0.49 D ± 0.16, 0.33 D ± 0.11, 0.32 D ± 0.13, 0.27 D ± 0.08, respectively. Age and ethnicity, but not sex, were independently associated with axial elongation. Among these myopic children, a 0.5 mm increase in axial length was associated with 1 D of myopia progression. Conclusions Younger baseline age was the strongest factor independently associated with faster myopic progression and greater axial elongation at 3 years. African American children had less myopic progression and axial elongation than the other ethnic groups.

The purpose of this study was to evaluate the adaptability of myopic children participating in the Correction of Myopia Evaluation Trial (COMET) to the use of progressive addition lenses (PALs) with a modified fitting protocol of setting the distance fitting cross 4 mm above the pupil center.COMET was a multicenter, randomized clinical trial to evaluate whether PALs vs. single-vision lenses (SVLs) slowed the rate of progression in children with juvenile-onset myopia over 3 years. Of the 469 children enrolled, 234 were assigned to SVLs and 235 were assigned to PALs (+2.00 D near addition), which were fit according to a standard study protocol with the fitting cross positioned 4 mm above the pupil center. The children's adaptability to the use of PALs was evaluated by comparing the frequency and reasons for problem visits, visual symptoms, cover test results, and adherence to wearing glasses between treatment groups.During the first 3 years of follow-up, no differences were observed between children wearing PALs and those wearing SVLs with respect to the number or reasons for problem visits. One week after receipt of the study glasses, children wearing PALs showed a higher frequency of three visual symptoms related to adaptability: looking down from the blackboard and getting items on their desk in focus (p = 0.001), blur when reading (p = 0.003), and difficulty going down steps (p = 0.02). Children wearing PALs were more likely to report at least one adaptation symptom at 1 week: odds ratio of 2.76 (95% confidence interval = 1.28-5.95). By 1 month, these differences disappeared and the frequency of all visual symptoms remained low and similar for both treatment groups over 3 years. Strabismus was observed on cover test in five children (three SVLs, two PALs). None of the children had to be changed from PALs to SVLs, whereas two of the children were changed from SVLs to PALs as a result of binocular vision problems. The children and parents reported adherence to wearing the eyeglasses approached 100% compliance throughout the follow-up period for both groups. Most (98%) of the 235 children assigned to PALs maintained the modified fitting protocol without any problems over 3 years.These data show that children can safely and comfortably wear PALs for at least 3 years.

PURPOSE To examine baseline measurements of accommodative lag, phoria, reading distance, amount of near work, and level of myopia as risk factors for progression of myopia and their interaction with treatment over 3 years, in children enrolled in the Correction of Myopia Evaluation Trial (COMET). METHODS COMET enrolled 469 ethnically diverse children (ages, 6-11 years) with myopia between -1.25 and -4.50 D. They were randomly assigned to either progressive addition lenses (PALs) with a +2.00 addition (n = 235) or single vision lenses (SVLs; n = 234), the conventional spectacle treatment, and were observed for 3 years. The primary outcome measure was progression of myopia by autorefraction after cycloplegia with 2 drops of 1% tropicamide. Other measurements included accommodative response (by an open field of view autorefractor), phoria (by cover test), reading distance, and hours of near work. Independent and interaction analyses were based on the mean of the two eyes. Results were adjusted for important covariates with multiple linear regression. RESULTS Children with larger accommodative lags (>0.43 D for a 33 cm target) wearing SVLs had the most progression at 3 years. PALs were effective in slowing progression in these children, with statistically significant 3-year treatment effects (mean +/- SE) for those with larger lags in combination with near esophoria (PAL - SVL progression = -1.08 D - [-1.72 D] = 0.64 +/- 0.21 D), shorter reading distances (0.44 +/- 0.20 D), or lower baseline myopia (0.48 +/- 0.15 D). The 3-year treatment effect for larger lags in combination with more hours of near work was 0.42 +/- 0.26 D, which did not reach statistical significance. Statistically significant treatment effects were observed in these four groups at 1 year and became larger from 1 to 3 years. CONCLUSIONS The results support the COMET rationale (i.e., a role for retinal defocus in myopia progression). In clinical practice in the United States children with large lags of accommodation and near esophoria often are prescribed PALs or bifocals to improve visual performance. Results of this study suggest that such children, if myopic, may have an additional benefit of slowed progression of myopia.

To describe the 4-year incidence of visual impairment and causes of blindness among black participants of the Barbados Eye Studies.Population-based incidence study.The Barbados Incidence Study of Eye Diseases (BISED) followed the cohort of the Barbados Eye Study (BES), a prevalence study based on a simple random sample of Barbadians 40 to 84 years of age. BISED included 3193 black participants from the original cohort (85% of those eligible).Best-corrected visual acuity (Ferris-Bailey chart) at baseline and follow-up was measured according to a modified Early Treatment of Diabetic Retinopathy Study protocol. By use of World Health Organization (WHO) criteria, low vision and blindness for an individual were defined as visual acuity (VA)6/18 to 6/120 and6/120, respectively, in the better eye. By commonly used US criteria, low vision and blindness were defined as VAor = 20/40 andor = 20/200, respectively. Vision loss was defined as a doubling of the visual angle (i.e., decrease of 15 letters or more read correctly between baseline and follow-up examinations). Progression was defined as vision loss among those with low vision at baseline.On the basis of WHO criteria, the overall 4-year incidence was 3.6% (95% confidence interval [CI], 3.0%-4.4%) for low vision and 0.6% (95% CI, 0.4%-1.0%) for blindness. Incidence rates were higher using US criteria: 5.3% (95 % CI, 4.5%-6.2%) and 1.5% (95% CI, 1.1%-2.0%), respectively, reaching 21.5% and 7.3% for persons aged 70 years or older at baseline. One tenth of the cohort had vision loss, and 28.6% of those with low vision progressed. About one half of incident blindness was due to age-related cataract. Nearly one fifth was caused by open-angle glaucoma (OAG) alone or combined with cataract, and approximately 10% was caused by diabetic retinopathy (DR).The incidence of visual impairment was high in this Afro-Caribbean population, particularly in older age groups, indicating the public health significance of visual loss for this and similar black populations. Cataract, OAG, and DR were among the leading causes of incident blindness, paralleling their high prevalence in this population.

Purpose To examine the 4-year incidence and risk factors for diabetic retinopathy (DR) among black participants with diabetes in the Barbados Eye Studies (BES). Design Population-based incidence study. Setting and participants Four hundred ten persons with diabetes mellitus (DM) from the BES cohort, which was based on a simple random sample of Barbadians, 40 to 84 years of age at baseline. Main outcome measures Development of DR, assessed by independent gradings of 30° color stereo fundus photographs of the disc and macula. Associations were evaluated by logistic regression analyses. Results After 4 years, DR developed in 92 of 306 (30.1%; 95% confidence interval, 25.0%, 35.5%) persons unaffected at baseline. The incidence of DR was 31.9% in those with known DM at baseline and 20.9% in newly diagnosed DM. Clinically significant macular edema developed in 16 (4.5%) of 353 individuals at risk. Seven (6.9%) of the 101 persons with minimum or moderate DR at baseline progressed to proliferative DR. Age-specific incidence declined from 36.2% at age 40 to 49 years to 28.8% and 24.2% over the subsequent two decades, increasing to 38.2% among those ≥70 years. Risk factors for DR were increased systolic blood pressure (relative risk [RR], 1.16 [1.03, 1.31]/10 mmHg increase); use of oral hypoglycemics (RR, 2.4 [1.3, 4.2]); and use of insulin (RR, 6.1 [1.7, 22.1]) (vs. no treatment or diet only); and elevated glycated hemoglobin (GHb; RR, 6.4 [2.5, 16.0]); GHb >11.5% vs. GHb ≤8%). Conclusions High rates of incident DR were evident in the black BES population, also known to have high rates of DM. Prevention of visual loss caused by DR in this population has high priority, including optimal glycemic and blood pressure control.

To describe longitudinal macular changes in a black population after 4 years of follow-up.Population-based incidence study.The Barbados Incidence Study of Eye Diseases (BISED) reexamined the Barbados Eye Study cohort, which was based on a random sample of the country's residents, 40 to 84 years. The BISED included 3427 persons, or 85% of the eligible cohort.Four-year incidence of macular changes, as determined by gradings of color stereoscopic macular photographs.Among black participants, the overall 4-year incidence of early macular changes (medium or large drusen or20 small drusen with retinal pigment epithelium [RPE] atrophy or pigment) was 5.2% (95% confidence interval, 4.0%-6.6%) and tended to be higher in women (5.8%) than in men (4.1%). Incidence of related features was 5.2% for medium drusen (64-250 microm), 0.3% for drusen250 microm, 1.1% for confluence, 0.5% for pigment, and 0.1% for RPE atrophy. Of the 2362 persons at risk for late macular changes (geographic atrophy, fluid, lipid, hemorrhage, disciform scar), exudative features developed in only 1 person in 4 years. Less than 1% of persons with early macular changes at baseline had disappearance of related features.After 4 years, the development of severe macular disease was rare in this black population, and the incidence of early macular changes also was lower than in other populations. Results are consistent with the low risk of macular degeneration in persons of African descent.

Objective To provide the results of the Early Manifest Glaucoma Trial, which compared the effect of immediately lowering the intraocular pressure (IOP), vs no treatment or later treatment, on the progression of newly detected open-angle glaucoma. Design Randomized clinical trial. Participants Two hundred fifty-five patients aged 50 to 80 years (median, 68 years) with early glaucoma, visual field defects (median mean deviation, −4 dB), and a median IOP of 20 mm Hg, mainly identified through a population screening. Patients with an IOP greater than 30 mm Hg or advanced visual field loss were ineligible. Interventions Patients were randomized to either laser trabeculoplasty plus topical betaxolol hydrochloride (n = 129) or no initial treatment (n = 126). Study visits included Humphrey Full Threshold 30-2 visual field tests and tonometry every 3 months, and optic disc photography every 6 months. Decisions regarding treatment were made jointly with the patient when progression occurred and thereafter. Main Outcome Measures Glaucoma progression was defined by specific visual field and optic disc outcomes. Criteria for perimetric progression were computer based and defined as the same 3 or more test point locations showing significant deterioration from baseline in glaucoma change probability maps from 3 consecutive tests. Optic disc progression was determined by masked graders using flicker chronoscopy plus side-by-side photogradings. Results After a median follow-up period of 6 years (range, 51-102 months), retention was excellent, with only 6 patients lost to follow-up for reasons other than death. On average, treatment reduced the IOP by 5.1 mm Hg or 25%, a reduction maintained throughout follow-up. Progression was less frequent in the treatment group (58/129; 45%) than in controls (78/126; 62%) ( P =.007) and occurred significantly later in treated patients. Treatment effects were also evident when stratifying patients by median IOP, mean deviation, and age as well as exfoliation status. Although patients reported few systemic or ocular conditions, increases in clinical nuclear lens opacity gradings were associated with treatment ( P = .002). Conclusions The Early Manifest Glaucoma Trial is the first adequately powered randomized trial with an untreated control arm to evaluate the effects of IOP reduction in patients with open-angle glaucoma who have elevated and normal IOP. Its intent-to-treat analysis showed considerable beneficial effects of treatment that significantly delayed progression. Whereas progression varied across patient categories, treatment effects were present in both older and younger patients, high- and normal-tension glaucoma, and eyes with less and greater visual field loss.

To describe baseline refractive and ocular component measures in children with myopia enrolled in the Correction of Myopia Evaluation Trial (COMET). COMET is a multicenter, randomized clinical trial to evaluate whether progressive-addition lenses slow the progression of juvenile-onset myopia compared with single-vision lenses.Four hundred sixty-nine children with myopia between -1.25 and -4.50 D spherical equivalent and without eye or systemic conditions known to affect refractive development were recruited from four geographically and ethnically diverse communities in the United States. Their ages were 6 to 11 years inclusive, and 52% were girls. The main outcome measure for the overall trial is progression of myopia determined by cycloplegic autorefraction after inducement of cycloplegia with 2 drops of 1% tropicamide. Axial length, the secondary outcome measure, was assessed by ultrasonography. The distance correction was determined by subjective methods before cycloplegia, with noncycloplegic autorefraction values as the starting point.Because data were similar in both eyes, they are reported for the right eye only. The mean spherical equivalent measured by cycloplegic autorefraction was -2.38 +/- 0.81 D. Young children had significantly less myopia than older children (P = 0.03), but the amount of myopia did not differ by gender or ethnicity. Mean axial dimensions were 4.0 +/- 0.2 mm (anterior chamber), 3.4 +/- 0.2 mm (lens), 16.8 +/- 0.7 mm (vitreous chamber), and 24.1 +/- 0.7 mm (axial length). Girls' eyes had significantly shorter axial length than boys' (P0.0001). Mean corneal radii were 7.73 +/- 0.25 mm (horizontal) and 7.59 +/- 0.24 mm (vertical). Ninety-five percent of the eyes had a ratio of axial length to corneal radius higher than 3.0.These baseline measures provide cross-sectional data on a large group of ethnically diverse children with myopia. Refractive and axial component dimensions are consistent with data in other studies showing that myopic eyes have longer vitreous chambers than emmetropic eyes. The measures reported herein will serve as a basis for examining changes that occur over a minimum of 3 years of follow-up of children enrolled in COMET.

Importance Chronic periodontitis, a destructive inflammatory disorder of the supporting structures of the teeth, is prevalent in patients with diabetes. Limited evidence suggests that periodontal therapy may improve glycemic control. Objective To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin (HbA 1c ) in persons with type 2 diabetes and moderate to advanced chronic periodontitis. Design, Setting, and Participants The Diabetes and Periodontal Therapy Trial (DPTT), a 6-month, single-masked, multicenter, randomized clinical trial. Participants had type 2 diabetes, were taking stable doses of medications, had HbA 1c levels between 7% and less than 9%, and untreated chronic periodontitis. Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers. Interventions The treatment group (n = 257) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months. The control group (n = 257) received no treatment for 6 months. Main Outcomes and Measures Difference in change in HbA 1c level from baseline between groups at 6 months. Secondary outcomes included changes in probing pocket depths, clinical attachment loss, bleeding on probing, gingival index, fasting glucose level, and Homeostasis Model Assessment (HOMA2) score. Results Enrollment was stopped early because of futility. At 6 months, mean HbA 1c levels in the periodontal therapy group increased 0.17% (SD, 1.0), compared with 0.11% (SD, 1.0) in the control group, with no significant difference between groups based on a linear regression model adjusting for clinical site (mean difference, −0.05% [95% CI, −0.23% to 0.12%]; P = .55). Periodontal measures improved in the treatment group compared with the control group at 6 months, with adjusted between-group differences of 0.28 mm (95% CI, 0.18 to 0.37) for probing depth, 0.25 mm (95% CI, 0.14 to 0.36) for clinical attachment loss, 13.1% (95% CI, 8.1% to 18.1%) for bleeding on probing, and 0.27 (95% CI, 0.17 to 0.37) for gingival index ( P Conclusions and Relevance Nonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis. These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA 1c . Trial Registration clinicaltrials.gov Identifier:NCT00997178

The authors' goal was to describe the characteristics of posttraumatic stress disorder (PTSD) symptoms on resettlement in the United States and at 1-year follow-up among Bosnian refugees as well as possible factors affecting the PTSD symptom profile among these refugees.They used standardized instruments to assess 34 Bosnian refugees for PTSD at resettlement in the United States and 1 year later.Fifteen of the refugees were diagnosed with PTSD at 1-year follow-up, compared with 25 at initial assessment. The average PTSD severity score at follow-up was 12.5, compared with 20.6 at initial assessment. At 1-year follow-up, 25 of the refugees experienced a decrease in severity of PTSD symptoms, one remained the same, and eight experienced an increase in severity. Older refugees were significantly more likely to have PTSD than younger refugees, and older refugees had more severe symptoms.The level of PTSD diagnosis and symptoms in Bosnian refugees remained substantial 1 year after their resettlement in the United States, although there were notable overall decreases. Older refugees appeared to be at greater risk.

The authors used the SCID-DES (disorders of extreme stress) instrument to assess for personality change in Bosnian survivors of “ethnic cleansing.” Twenty four refugees underwent systematic, trauma-focused, research assessments, including the SCID-DES interview. Overall, this group of Bosnian survivors had been severely traumatized as a result of the Serbian nationalists' genocide. However, no subject met diagnostic criteria for DES. The SCID-DES yields far lower rates of trauma-related personality change in Bosnian survivors of genocide than in adult survivors of prolonged early life traumas. Therefore, the DES construct may have better application to prolonged, interpersonal, early life traumas than to the prolonged, communal traumas of genocide.

This is a case study of a family that survived genocide and a discussion of families and massive psychic trauma. This family, like many others from Bosnia-Herzegovina, was driven from their home by Serb forces-"ethnically cleansed"-then eventually escaped to Croatia, and was later resettled in the United States. They were referred to us, a group of mental health professionals who established the Bosnian Refugee Trauma Program at the Yale Psychiatric Institute (YPI). We have done clinical, testimony, and research work with the refugee families from Bosnia who resettled in our region, described in part in prior reports (Weine, Becker et al. 1995a, 1995b; Weine and Laub 1995).

Objective: To evaluate risk factors for open-angle glaucoma among black participants in the Barbados Eye Study. Design: Population-based study of demographic, medical, ocular, familial, and other factors possibly related to open-angle glaucoma. Setting and Participants: The Barbados Eye Study included 4709 Barbados residents identified by a simple random sample of Barbadian-born citizens, 40 to 84 years of age; participation was 84%. This report is based on the 4314 black participants examined at the study site; 302 (7%) met the Barbados Eye Study criteria for open-angle glaucoma. Data Collection: A standardized protocol included applanation tonometry, Humphrey perimetry, fundus photography, blood pressure, anthropometry, and an interview. An ophthalmologic examination was performed for participants who met specific criteria. Main Outcome Measures: Open-angle glaucoma was defined by the presence of both characteristic visual field defects and optic disc damage. Association of open-angle glaucoma with specific factors was evaluated in logistic regression analyses. Results: Age, male gender, high intraocular pressure, and family history of open-angle glaucoma were major risk factors; the latter association was stronger in men than women. Lean body mass and cataract history were the only other factors related to open-angle glaucoma. Although hypertension and diabetes were common in Barbados Eye Study participants, they were unrelated to the prevalence of open-angle glaucoma. However, associations were found with low diastolic blood pressure-intraocular pressure differences and low systolic and diastolic blood pressure/intraocular pressure ratios. Conclusions: In the Barbados Eye Study black population, persons most likely to have open-angle glaucoma were older men and had a family history of open-angle glaucoma, high intraocular pressure, lean body mass, and cataract history. These results suggest the importance of possible genetic or familial factors in open-angle glaucoma. The role of vascular risk factors is consistent with our finding of low blood pressure to intraocular pressure relationships, but the results could be explained by the high intraocular pressure in open-angle glaucoma.