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Objective: To describe health- and vision-targeted quality of life following treatment with iodine 125 brachytherapy vs enucleation for choroidal melanoma in a subgroup of patients who were treated and observed prospectively as part of a large randomized clinical trial. Main Outcome Measures: Difficulty with driving, near vision activities, and activities using stereopsis or binocularity; anxiety; and depression Participants: Two hundred nine patients who enrolled in the Collaborative Ocular Melanoma Study trial for medium-sized tumors between March 1995 and July 1998 and gave informed consent prior to randomization to participation in an ancillary study of quality of life. Methods: Patients were interviewed by telephone by a trained interviewer from the Collaborative Ocular Melanoma Study Coordinating Center at baseline (prior to randomization), at 6 months, and on annual anniversaries of enrollment. The questionnaire battery included the Medical Outcomes Study Short Form 36, the Activities of Daily Vision Scale, the National Eye Institute Visual Function Questionnaire, and the Hospital Anxiety and Depression Scale. Additional questions concerning satisfaction with posttreatment appearance and concerns about cancer recurrence also were included in posttreatment interviews. Results: There was a significant increase in both treatment groups in levels of reported difficulty for most vision oriented activities, and in bodily and ocular pain, 6 months following treatment. Differences in visual function between treatment groups reported during follow-up were relatively small, but significant differences favoring brachytherapy-treated patients were observed for driving during the first year of follow-up and for peripheral vision during the first 2 years of follow-up. Anxiety levels in both groups decreased significantly following treatment, but patients treated with brachytherapy with symptoms of anxiety were less likely to report later resolution of symptoms than patients with symptoms of anxiety who were treated with enucleation. This study was unable to assess impact of treatment on satisfaction with appearance and concern about cancer recurrence during the first year after treatment, but no treatment-related differences were found on these measures at 2 years and later follow-up times. Conclusions: Patients treated with brachytherapy reported significantly better visual function than patients treated with enucleation with respect to driving and peripheral vision for up to 2 years following treatment. Differences between treatments in visual function diminished by 3 to 5 years posttreatment, paralleling decline in visual acuity in brachytherapy-treated eyes. Patients treated with brachytherapy were more likely to have symptoms of anxiety during follow-up than patients treated with enucleation. Application to Clinical Practice: Given that no significant differences in survival between enucleation and brachytherapy have been found, the differences demonstrated here for driving and anxiety will allow the individual patient and physician to make informed choices regarding treatment based on personal preferences. [ABSTRACT FROM AUTHOR]

Presents findings of a study which tested the effect of angiopoietin 2 (Ang2) on blood vessels. Impact of increased expression of Ang2 on mature retinal blood vessels; Contribution of Ang2 expression to stimulation of retinal neovascularization; Discussion on Ang2 inhibition of subretinal neovascularization in rho/vascular endothelial growth factor transgenic mice

Purpose To assess the internal consistency of a short, widely-used health-related quality of life instrument in patients with choroidal melanoma, its appropriateness for use in a large clinical trial in patients with that disease, and the feasibility of various methods of instrument administration. Methods The SF-36 was administered to 31 choroidal melanoma patients identified from two ocular oncology practices. Fifteen patients were interviewed by telephone, 4 were interviewed in person at the clinic, and 12 patients completed the instrument themselves while at the clinic. Results Twenty-three patients had already been treated for choroidal melanoma; 20 patients were treated with some form of radiation. The remaining 8 patients had not yet been treated. Metastasis had not been diagnosed in any of the patients. Patient age ranged from 37 to 85 years with a median of 59 years; 55% of the patients were female. The in-person and telephone interviews performed better than self-administered interviews in terms of missing items due to non-response (0% vs. 3.2%). The overall SF-36 health profile for the choroidal melanoma patients was similar in shape to that expected for a general U.S. population sample with the same age and gender distribution, although the choroidal melanoma patients averaged 4 to 11 points higher, indicating better health-related quality of life, for all scales except the role functioning-emotional scale. Conclusions: The results supported the internal consistency of the SF-36 in this population. Interviewer administration of the SF-36 either in-person or by telephone was acceptable to the patients and provided more complete data. [ABSTRACT FROM AUTHOR]

The Collaborative Ocular Melanoma Study (COMS) is a set of randomized clinical trials sponsored by the National Eye Institute of the National Institutes of Health. The COMS is being conducted to evaluate the role of radiotherapy in the treatment of patients with choroidal melanoma. Primary choroidal melanoma can enlarge or metastasize and eventually cause death in a significant percentage of cases. The primary COMS trial is designed to determine whether enucleation (removal of the eye) or radiotherapy without removal of the eye provides the patient with the longest remaining lifespan. More than 40 clinical centers in the United States and Canada are participating in the COMS. The objective of the COMS is to assess the effect of treatment upon 5-year and 10-year survival and the reduction or elimination of the disease process in patients randomly assigned to receive either radiation or enucleation. An ancillary component of the COMS, referred to as the COMS-QOLS, was designed to measure the impact of disease and its treatment on quality of life. The two treatment approaches being investigated, enucleation and radiation therapy, are likely to have different psychological and physiological effects on the patients receiving them. The COMS-QOLS assessments include the SF-36 Health Survey, the Activities of Daily Vision Scale (ADVS), the Visual Functioning Questionnaire (VFQ), and the Hospital Anxiety and Depression Scale (HADS). Patients are interviewed at selected intervals during follow-up; in addition, 200 patients will be interviewed before randomization and have repeat interviews at six months and annually after randomization. The patient's quality of life after treatment will become an important consideration in determining the best form of therapy, particularly in the event that no survival difference between treatment groups is found. [ABSTRACT FROM AUTHOR]

Objective: To compare visual acuity (VA) scores after autorefraction versus research protocol manual refraction in eyes of patients with diabetes and a wide range of VA. Methods: Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) VA Test© letter score (EVA) was measured after autorefraction (AR-EVA) and after Diabetic Retinopathy Clinical Research Network (DRCR.net) protocol manual refraction (MR-EVA). Testing order was randomized, study participants and VA examiners were masked to refraction source, and a second EVA utilizing an identical manual refraction (MR-EVAsupl) was performed to determine test-retest variability. Results: In 878 eyes of 456 study participants, median MR-EVA was 74 (Snellen equivalent approximately 20/32). Spherical equivalent was often similar for manual and autorefraction (median difference: 0.00, 5th and 95th percentiles −1.75 to +1.13 Diopters). However, on average, MR-EVA results were slightly better than AR-EVA results across the entire VA range. Furthermore, variability between AR-EVA and MR-EVA was substantially greater than the test-retest variability of MR-EVA (P<0.001). Variability of differences was highly dependent on autorefractor model. Conclusions: Across a wide range of VA at multiple sites using a variety of autorefractors, VA measurements tend to be worse with autorefraction than manual refraction. Differences between individual autorefractor models were identified. However, even among autorefractor models comparing most favorably to manual refraction, VA variability between autorefraction and manual refraction is higher than the test-retest variability of manual refraction. The results suggest that with current instruments, autorefraction is not an acceptable substitute for manual refraction for most clinical trials with primary outcomes dependent on best-corrected VA.

The article discusses research which compared intravitreous aflibercept, bevacizumab and ranibizumab for the treatment of diabetic macular edema. Topics covered include the improvement in the mean visual-acuity letter score of study participants, the lack of significant differences in the rates of adverse events and hospitalization and the efficacy of aflibercept in improving vision.

Purpose: The purpose of this study was to evaluate self-reported functional vision (FV) and the impact of vision loss in patients with USH2A-associated retinal degeneration using a patient-reported outcome (PRO) measure, the Michigan Retinal Degeneration Questionnaire (MRDQ), to correlate MRDQ scores with well-established visual function measurements., Design: An observational cross-sectional study (n = 93) of participants who had Usher Syndrome Type 2 (USH2, n = 55) or autosomal recessive non-syndromic retinitis pigmentosa (ARRP; n = 38) associated with biallelic variants in the USH2A gene., Methods: The study protocol was approved by all ethics boards and informed consent was obtained from each participant. Participants completed the MRDQ at the 48-month study follow-up visit. Disease duration was self-reported by participants. One-way ANOVA was used to compare subgroups (clinical diagnosis, age, disease duration, and full-field stimulus threshold [FST] Blue-Red mediation) on mean scores per domain. Spearman correlation coefficients were used to assess associations between MRDQ domains and visual/retinal function assessments., Results: Of the study sample, 58% were female participants and the median disease duration was 13 years. MRDQ domains were sensitive to differences between subgroups of clinical diagnosis, age, disease duration, and FST Blue-Red mediation. MRDQ domains correlated with static perimetry, microperimetry, full-field stimulus testing, and best-corrected visual acuity (BCVA)., Conclusions: Self-reported FV measured by the MRDQ, when applied to USH2 and ARRP participants, had good distributional characteristics and correlated well with visual function tests. MRDQ adds a new dimension of understanding on vision-related functioning and establishes this PRO tool as an informative measure in evaluating USH2A outcomes.

Purpose: Evaluate association of retinal nonperfusion (NP) on ultrawide field (UWF) fluorescein angiography (FA) with diabetic retinopathy (DR) severity and predominantly peripheral lesions (PPL)., Methods: Multicenter observational study, 652 eyes (361 participants) having nonproliferative DR (NPDR) without center-involved diabetic macular edema in at least one eye. Baseline 200° UWF-color and UWF-FA images were graded by a central reading center for color-PPL and FA-PPL, respectively. UWF-FA was graded for NP index within concentric zones: posterior pole (<10 mm from fovea), midperiphery (10-15 mm), and far periphery (>15 mm)., Results: Baseline Early Treatment Diabetic Retinopathy Study DR severity was 31.7% no DR/mild NPDR, 24.1% moderate NPDR, 14.0% moderately severe NPDR, 25.6% severe/very severe NPDR, and 4.6% proliferative DR. Worse DR severity was associated with increased NP index overall (P = 0.002), in the posterior pole (P < 0.001), midperiphery (P < 0.001), and far periphery (P = 0.03). On average, 29.6% of imaged retinal NP was in the posterior pole, 33.7% in midperiphery, and 36.7% in far periphery. Increased NP index was associated with FA-PPL (P < 0.001) but not with color-PPL (P = 0.65)., Conclusion: Approximately, 70% of NP in diabetic eyes is located outside the posterior pole. Increased NP is associated with the presence of FA-PPL, suggesting UWF-FA may better predict future DR worsening than UWF-color alone.

Purpose: To explore optical coherence tomography angiography (OCTA) quality and associated factors in multicenter clinical studies., Methods: OCTA scans were obtained from participants with diabetic retinopathy from three DRCR Retina Network clinical studies using the Optovue AngioVue and ZEISS AngioPlex. Macular (3 × 3 mm and 6 × 6 mm) and optic nerve scans were captured. Quality was assessed by the Casey Reading Center. Scans were considered "poor" if the signal strength index (SSI) was less than 55 (AngioVue) or 7 (AngioPlex) or if excess motion, media opacities, beam defocus, incorrect axial position, or other artifacts were present., Results: Included were 7539 scans from 787 eyes (461 participants). Sixty-one percent of scans were considered "good" (n = 4630). Of the 3 × 3-mm (n = 2294), 6 × 6-mm (n = 2705), and optic nerve scans (n = 2540), 62%, 63%, and 59%, respectively, were good. Differences in percentage of good scans by machine were not identified (61% of 6216 for the AngioVue and 63% of 1323 for the AngioPlex). The primary reason for poor scans was low SSI for the AngioVue (67%) and excess motion for the AngioPlex (47%). Good scans were associated with younger age (60 ± 12 years vs. 65 ± 11 years; P < 0.001), male gender (64% of males had good scans vs. 57% female; P = 0.007), and better visual acuity (ETDRS letter score 86.5 ± 6.4 [approximate Snellen equivalent 20/20] vs. 81.6 ± 9.7 [approximate Snellen equivalent 20/25]; P < 0.001)., Conclusions: Scan quality or analysis must be improved for OCTA metrics to be used as outcomes in future research., Translational Relevance: Clinicians and researchers should be aware that poor SSI and artifacts are common issues for OCTA images.

Purpose: To describe 2.5% low-contrast visual acuity (VA) among eyes with good vision despite center-involved diabetic macular edema and compare changes after initial management with aflibercept, laser, or observation., Methods: This was an ancillary study within a multicenter randomized clinical trial (DRCR Retina Network Protocol V). Participants had diabetes and 1 study eye with center-involved diabetic macular edema and a VA of 20/25 or better randomly assigned to aflibercept (n = 112), focal/grid laser (n = 146), or observation (n = 129). Eyes in the laser and observation groups received aflibercept if VA met prespecified worsening criteria., Results: Participants had median age of 60 years, 37% were female and 70% were non-Hispanic White. At baseline, the mean ± standard deviation (SD) high-contrast VA was 85.2 ± 3.6 letters (Snellen equivalent 20/20), mean ± SD 2.5% low-contrast VA was 47.6 ± 18.9 letters (Snellen equivalent 20/125), and low-contrast VA letter score was 2 SDs or more below the age-specific normative values in 23%. At 2 years, the mean change ± SD in low-contrast VA in the aflibercept, laser, and observation groups was 2.7 ± 20.1, -2.0 ± 19.6, and -3.1 ± 20.8 letters (adjusted difference, aflibercept vs. laser, 5.3 [95% confidence interval, -0.2 to 10.8], P = 0.06; aflibercept vs. observation, 5.5 [95% confidence interval -0.2 to 11.2], P = 0.06; and laser vs. observation, 0.2 [95% confidence interval -4.6 to 5.0], P = 0.94)., Conclusions: There was no significant difference between treatment groups in low-contrast VA change from baseline to 2 years. Considering the range of the 95% confidence intervals, however, the study may have been underpowered to detect a clinically meaningful benefit between treatment groups., Translational Relevance: Low-contrast VA, an important visual function, is decreased in eyes with diabetic macular edema.

Purpose: Compare changes in retinal nerve fiber layer (RNFL) thickness between eyes assigned to intravitreous ranibizumab or panretinal photocoagulation and assess correlations between changes in RNFL and visual field sensitivity and central subfield thickness., Methods: Eyes with proliferative diabetic retinopathy were randomly assigned to ranibizumab or panretinal photocoagulation. Baseline and annual follow-up spectral domain optical coherence tomography RNFL imaging, optical coherence tomography macular imaging, and automated static perimetry (Humphrey visual field 60-4 algorithm) were performed., Results: One hundred forty-six eyes from 120 participants were analyzed. At 2 years, for the ranibizumab (N = 74) and panretinal photocoagulation (N = 66) groups, respectively, mean change in average RNFL thickness was -10.9 ± 11.7 μm and -4.3 ± 11.6 μm (difference, -4.9 μm; 95% confidence interval [-7.2 μm to -2.6 μm]; P < 0.001); the correlation between change in RNFL thickness and 60-4 Humphrey visual field mean deviation was -0.27 (P = 0.07) and +0.33 (P = 0.035); the correlation between change in RNFL thickness and central subfield thickness was +0.63 (P < 0.001) and +0.34 (P = 0.005), respectively., Conclusion: At 2 years, eyes treated with ranibizumab had greater RNFL thinning than eyes treated with panretinal photocoagulation. Correlations between changes in RNFL thickness, visual field, and central subfield thickness suggest that the decrease in RNFL thickness with ranibizumab is likely due to decreased edema rather than loss of axons.

Purpose: To evaluate the reproducibility of central subfield thickness (CST) and volume measurements from optical coherence tomography (OCT) images obtained with Zeiss Stratus and Optovue RTVue, and formulate equations to convert these measurements from RTVue to 'equivalent' Stratus values., Methods: Cross-sectional observational study from 309 eyes of 167 participants with diabetes and at least one eye with central-involved diabetic macular edema (DME; Stratus CST ≥ 250 μm) that underwent two replicate Stratus scans followed by two replicate RTVue scans centered on the fovea., Results: The Bland-Altman coefficient of repeatability for relative change in CST (the degree of change that could be expected from measurement variability) was not significantly different on Stratus and RTVue scans (10% and 16%, respectively). The replicate Stratus CST was within 10% of the initial Stratus measurement 93% of the time; the CST conversion equation predicted a Stratus value calculated from the observed RTVue value within 10% of the observed Stratus thickness 91% of the time. Bland-Altman limit of agreement for relative change in CST between measurements observed on different machines was 23%, comparing predicted versus actual Stratus measurement., Conclusions: RTVue thickness reproducibility appears similar to Stratus. Conversion equations to transform RTVue measurements to Stratus-equivalent values within 10% of the observed Stratus RT are feasible. CST changes greater than 10% when using the same machine or 20% when switching from Stratus to RTVue, after conversion to Stratus equivalents, are likely due to a true change beyond measurement error., Translational Relevance: Conversion equations to translate central retinal thickness measurements between OCT instruments is critical to clinical trials.

Objective: To report the outcome of nasolacrimal duct probing as the primary treatment of congenital nasolacrimal duct obstruction (NLDO) in children younger than 4 years., Design: Prospective nonrandomized observational multicenter study (44 sites)., Participants: Nine hundred fifty-five eyes of 718 children 6 to <48 months old at the time of surgery with no prior nasolacrimal surgical procedure and with at least one of the following clinical signs of NLDO present: epiphora, mucous discharge, and increased tear lake., Intervention: Probing of the nasolacrimal system of the affected eye., Main Outcome Measure: Treatment success was defined as no epiphora, mucous discharge, or increased tear lake present at the outcome visit 1 month after surgery., Results: Proportions of eyes treated successfully were 78% (95% confidence interval [CI], 75%-81%) overall, 78% for the 421 eyes in children 6 to <12 months old, 79% for the 421 eyes in children 12 to <24 months, 79% for the 37 eyes in children 24 to <36 months, and 56% for the 11 eyes in children 36 to <48 months. The probability of treatment success was lower in eyes operated in an office setting than in eyes operated in a surgical facility (adjusted relative risk, 0.88 [95% CI, 0.80-0.96]), with success reported in 72% (95% CI, 66%-78%) of probings performed in an office and 80% (95% CI, 77%-84%) of probings performed in a facility. The probability of treatment success was also lower in eyes of patients with bilateral disease (adjusted relative risk, 0.88 [95% CI, 0.81-0.95])., Conclusions: In children 6 to <36 months old, probing is a successful primary treatment of NLDO in about three fourths of cases, with no decline in treatment success with increasing age. The study enrolled too few children ages 36 to <48 months to allow a conclusion regarding the probability of treatment success in this age group.

Objective: To compare 2 hours of daily patching (combined with 1 hour of concurrent near visual activities) with a control group of spectacle wear alone (if needed) for treatment of moderate to severe amblyopia in children 3 to 7 years old., Design: Prospective randomized multicenter clinical trial (46 sites)., Participants: One hundred eighty children 3 to 7 years old with best-corrected amblyopic-eye visual acuity (VA) of 20/40 to 20/400 associated with strabismus, anisometropia, or both who had worn optimal refractive correction (if needed) for at least 16 weeks or for 2 consecutive visits without improvement., Intervention: Randomization either to 2 hours of daily patching with 1 hour of near visual activities or to spectacles alone (if needed). Patients were continued on the randomized treatment (or no treatment) until no further improvement was noted., Main Outcome Measure: Best-corrected VA in the amblyopic eye after 5 weeks., Results: Improvement in VA of the amblyopic eye from baseline to 5 weeks averaged 1.1 lines in the patching group and 0.5 lines in the control group (P = 0.006), and improvement from baseline to best measured VA at any visit averaged 2.2 lines in the patching group and 1.3 lines in the control group (P<0.001)., Conclusion: After a period of treatment with spectacles, 2 hours of daily patching combined with 1 hour of near visual activities modestly improves moderate to severe amblyopia in children 3 to 7 years old.

Objective: To evaluate the effectiveness of refractive correction alone for the treatment of untreated anisometropic amblyopia in children 3 to <7 years old., Design: Prospective, multicenter, noncomparative intervention., Participants: Eighty-four children 3 to <7 years old with untreated anisometropic amblyopia ranging from 20/40 to 20/250., Methods: Optimal refractive correction was provided, and visual acuity (VA) was measured with the new spectacle correction at baseline and at 5-week intervals until VA stabilized or amblyopia resolved., Main Outcome Measures: Maximum improvement in best-corrected VA in the amblyopic eye and proportion of children whose amblyopia resolved (interocular difference of < or =1 line) with refractive correction alone., Results: Amblyopia improved with optical correction by > or =2 lines in 77% of the patients and resolved in 27%. Improvement took up to 30 weeks for stabilization criteria to be met. After stabilization, additional improvement occurred with spectacles alone in 21 of 34 patients observed in a control group of a subsequent randomized trial, with amblyopia resolving in 6. Treatment outcome was not related to age, but was related to better baseline VA and lesser amounts of anisometropia., Conclusion: Refractive correction alone improves VA in many cases and results in resolution of amblyopia in at least one third of 3- to <7-year-old children with untreated anisometropic amblyopia. Although most cases of resolution occur with moderate (20/40-20/100) amblyopia, the average 3-line improvement in VA resulting from treatment with spectacles may lessen the burden of subsequent amblyopia therapy for those with denser levels of amblyopia.

Objective: To develop and validate scales measuring common concerns of patients with choroidal melanoma: perception of appearance, concern about cancer recurrence, and difficulty with vision-dependent activities requiring stereopsis or binocularity., Design: Cross-sectional study within a randomized multicenter clinical trial., Methods: Eight-hundred forty-two of 1317 patients with choroidal melanoma enrolled in the Collaborative Ocular Melanoma Study (COMS) for medium-sized tumors and randomized to receive iodine 125 brachytherapy or enucleation were interviewed. Scale reliability was evaluated using Cronbach's alpha, and validity was investigated through correlation with existing scales and with data collected during COMS clinical examinations., Results: All 3 proposed scales had good internal consistency reliability. The appearance and recurrence scales had low to moderate correlation with the 36-Item Short-Form Health Survey mental health scale (r = 0.26 and 0.31, respectively) and with the the Hospital Anxiety and Depression Scale depression (r = -0.22 and -0.19) and anxiety (r = -0.27 and -0.42) scales. Appearance scores were significantly associated with occurrence of appearance-altering complications and conditions, recurrence scores were associated with recent removal of the brachytherapy-treated eye, and stereopsis/binocularity scores were higher in patients with good visual acuity in both eyes than in those with good visual acuity in one eye and an enucleated fellow eye., Conclusions: All 3 proposed scales have good internal consistency, range, and SDs of measurement in the tested population. Based on clinical data, there is evidence of good construct validity for all 3 scales, although there also is evidence that the stereopsis/binocularity scale is sensitive to other aspects of vision in addition to stereopsis and binocularity. The appearance and recurrence scales capture clinically relevant information not available from standard mental health scales.