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PURPOSE To present visual acuity (VA) and related findings from patients enrolled in one of the Submacular Surgery Trials (SST) evaluating surgical removal versus observation of subfoveal choroidal neovascularization secondary to age-related macular degeneration (SST Group N Trial). DESIGN Randomized clinical trial. PARTICIPANTS Eligible patients had age-related macular degeneration with subfoveal choroidal neovascularization, some with a classic pattern on fluorescein angiography, and best-corrected VA (BCVA) of 20/100 to 20/800 in one eye (study eye) that had received no treatment in the macula. Any contiguous blood had to account for

To describe visual acuity (VA) testing and scoring methods used in multicenter randomized clinical trials in ophthalmology in the United States (USA) sponsored by the National Eye Institute (NEI).A survey was conducted among multicenter studies in the US that included one or more randomized clinical trials and were sponsored by the NEI, National Institutes of Health. To be included in the survey, a study had to have VA reported in one or more publications or patient eligibility based on VA, a majority of study subjects 13 years of age or older, and a patient population primarily or exclusively from the US. A standard survey form was completed for each study based on information presented in the study manual of procedures and publications. Findings were summarized and displayed with frequency distributions.The survey included 24 studies, each with enrollment initiated in the period 1972 to 1999. VA was one of the study eligibility criteria for 19 (79%) studies, and VA or change in VA was the primary outcome in 12 (50%) studies. ETDRS charts have been employed in 16 of 19 studies initiated after the charts were published in 1982. All studies but one specified in the documents reviewed that VA testing was performed at multiple VA test distances. For studies that used ETDRS charts, methods of converting VA scores obtained at different test distances to a common scale fell into two categories: 11 studies used a method similar in nature to that first reported in the Macular Photocoagulation Study, and 7 studies used a method similar in nature to that first reported in the Krypton-Argon Regression of Neovascularization Study. conclusion The development of the ETDRS charts and a custom light box has led to more uniformity in VA test charts and chart illumination. However, details of VA measurement protocols vary widely from study to study. To assure comparable data across studies and ocular conditions, it would be useful to have a standard VA testing and scoring protocol with provisions for testing different levels of visual acuity that recommends a single method for converting scores from different test distances to a common scale and standard conversion of "off the chart" VA levels for calculation of means and changes in VA.

To describe the methods used by the Collaborative Ocular Melanoma Study (COMS) Echography Center for grading tumor echograms and to assess reliability of the grading system.Tumor echograms were graded at the COMS Echography Center using a specific protocol. To assess consistency, a five-percent random sample of all echographic gradings received as of June 30, 1996 was selected by the COMS Coordinating Center for re-evaluation at the COMS Echography Center. The results were compared with original data. Agreement between the two sets of gradings was evaluated by calculating overall percent agreement, and by using the kappa statistic for categorical features and intra-class correlation coefficients (ICC) for continuous measures.Overall agreement between original gradings and regradings was high. Agreement, based on the kappa statistic, between the original grading and the regrading was classified as 'moderate,' 'substantial,' or 'almost perfect' for nearly every variable graded. Kappas ranged from 0.47 for extrascleral extension to 0.82 for tumor shape. Intra-class correlation coefficients were 0.99 or higher for tumor height measurements and for the clock hour designation of the tumor apex. The only variable graded by the COMS Echography Center that did not have good agreement was 'confidence in tumor measurement.'The level of agreement (after adjusting for chance agreement) ranged from 'moderate' to 'almost perfect.' Grading for 'confidence of tumor measurement' differed between the original grading and the regrading but there was little difference in the tumor measurements. The COMS Echography Center has demonstrated that its grading protocol is consistent over time.

Objective To describe a cohort of patients with pars planitis followed at a single tertiary care institution, determine the frequency of multiple sclerosis and/or optic neuritis in patients with this disorder, and calculate gene frequencies of human leukocyte antigen (HLA) class II alleles in these patients. Design Fifty-three patients with the diagnosis of pars planitis underwent clinical record review or telephone interview for follow-up or both; 32 of these underwent phlebotomy for analysis of HLA class II alleles. Main outcome measures Outcomes included visual acuity, occurrence of multiple sclerosis and/or optic neuritis, and HLA class II gene frequencies. Results With a mean follow-up of 2 years, approximately 90% of patients maintained a visual acuity better than 20/40 in at least one eye. The most frequently encountered ophthalmic complications included cystoid macular edema, cataract, and epiretinal membrane formation. Of 37 patients with pars planitis who had medical or neurologic follow-up evaluations, 6 (16.2%) developed multiple sclerosis. The HLA-DR15 allele, coding for one of the two HLA-DR2 subtypes, was associated with pars planitis (odds ratio=2.86, 95% confidence interval=1.42–5.78, P = 0.004). Conclusions A common immunogenetic predisposition to multiple sclerosis and pars planitis may be associated with the HLA-DR15 allele. This association may represent genetic linkage to the HLA-DR locus or a role for the HLA-DR15 gene product in the pathogenesis of both of these diseases.

Purpose: The purpose of the study is to evaluate a recent series of patients who presented with open-globe injuries and to compare this series with a previous series collected at the authors' institution to determine whether prognostic factors or visual outcomes have changed. Methods: A retrospective review of 290 eyes of consecutive patients who presented to the Wilmer Ophthalmological Institute with open-globe injuries between December 1985 and January 1993 (group B) was compared with a series of 476 eyes with openglobe injury treated and evaluated at this institute between January 1970 and December 1981 (group A). For comparison, the outcomes evaluated included rates of enucleation and final visual acuity. Results: Several factors identified previously in group A to correlate with visual outcomes also were found to correlate significantly ( P P = 0.02). The incidence of enucleation was lower in group B (24%) than in group A (30%). However, the percentage of patients who achieved ambulatory visual acuity (5/200) or better was similar in both groups (57%, group A versus 55%, group B). Conclusion: Prognostic factors identified previously proved valid in this recent series. Visual outcomes have improved at this institution in the last 20 years for patients with severe ocular trauma, although visual potential for these patients is still limited.

Purpose: Previous studies have documented a 3% to 15.5% risk of retinal redetachment in eyes with prior scleral buckling procedures that later undergo intracapsular or extracapsular cataract extraction. The authors reviewed the records of patients with a history of retinal detachment (RD) surgery and subsequent phacoemulsification to assess the risk of retinal redetachment and the visual outcomes. Methods: Forty-seven eyes of 44 patients with a history of scleral buckling surgery who subsequently underwent phacoemulsification were identified. Features found before, during, and after surgery were reviewed. Results: No retinal redetachments occurred on a mean follow-up of 2.3 years. Eyes with RD repair were more myopic than fellow eyes ( P = P = 0.001), had steeper keratometry readings ( P = 0.03), and had larger differences in K readings between principal meridians ( P = 0.01). Postoperative visual acuity was 20/40 or better in 72.3% of eyes and 20/80 or worse in 6.4% of eyes. Preexisting macular pathology was responsible for poor outcomes. Conclusion: The risk of redetachment after phacoemulsification in eyes with previous RD surgery is low. Despite retinal and cataract surgery, these eyes can achieve useful vision.

Earlier detection of childhood vision disorders is a prominent goal of vision screening. The Medical Technology and Innovation (MTI) PhotoScreener addresses this objective. Use of this camera does not require verbal feedback and may be administered early in a child's development. Decreasing the variability in photograph grading results will boost the utility of any photoscreening system. This report aims to understand and to decrease intra- and inter-observer variability in grading photoscreening photographs.We dissected the photograph grading process and quantified the intra- and inter-observer agreement using intraclass plot correlation coefficients. We evaluated the outcome of a two grader verification system vs. adjudicated measurements with Receiver Operator Characteristic (ROC) curves.Data on 955 children under 5 years of age, normal except for refractive error, each with complete photoscreening and eye examination data, culled from two previous studies.Intra- and inter-observer agreement in measuring bright crescent dimensions and pupillary diameters. Sensitivity and specificity of detection of hyperopia.Measurements of bright crescents are associated with greater variability than are measurements of pupillary diameters. Recognition and omission of light "rim" measurements from photograph grading will result in superior inter-observer agreement. Photograph independent errors increase variability and may be corrected by remeasurement. A verification system in which the most discrepant 5% of measurements are redone results in ROC curves similar to adjudicated dimension.We conclude: 1) two novices grading photographs can do as well as one expert in most cases; 2) the proposed grading methodology has undergone statistical validation and can be used in other areas of ophthalmology and medicine; and 3) inter-observer variability, one of the limitations of photoscreening photograph grading, can be reduced. For 95% of the photographs, two novices achieve similar true positive and true negative values with or without adjudication.

To describe methods and results and to assess the value of a Traveling Vision Examiner (TVE) Program designed to provide masked vision measurements by expert vision examiners who were independent of, and traveled to, local clinical centers.The Submacular Surgery Trials (SST) Pilot Study was conducted to refine the design and methods for a set of multicenter, randomized clinical trials to evaluate submacular surgery in patients with subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) or ocular histoplasmosis (OHS), or idiopathic CNV in which the primary study outcome would be change in 2-year best-corrected vision from baseline. As part of the SST Pilot Study, the feasibility and value of a TVE Program was assessed. The goal of the program was to obtain unbiased vision measurements, according to a standard protocol, of best-corrected visual acuity, reading speed, and contrast threshold, of each patient at 2 and 4 years after enrollment.Eighty-three visits by TVEs were made to 16 centers participating in the SST Pilot Study; 239 patients had at least one masked vision examination. Comparison of pairs of vision measurements of the traveling vision examiners and local vision examiners for 71 patients made on the same day showed good agreement overall (intraclass correlation coefficientor = 0.81).The proposed TVE Program was judged to be a feasible and useful method of providing standardized, unbiased, masked vision measurements. This approach was incorporated into the larger clinical trials conducted by the SST Research Group.

Purpose To describe the guidelines followed by the Submacular Surgery Trials (SST) Research Group in the interpretation of color fundus photographs and fluorescein angiograms of subfoveal choroidal neovascular lesions evaluated in the SST and to assist ophthalmologists in applying the results of the SST. Methods Stereoscopic color fundus photographs and fluorescein angiograms of the study eye and nonstudy eye of 1,015 patients with subfoveal choroidal neovascular lesions secondary to age-related macular degeneration, ocular histoplasmosis syndrome, or idiopathic choroidal neovascularization (CNV) were obtained and graded by certified SST fundus photograph readers at the baseline examination in three randomized clinical trials comparing surgery with observation. Adherence to the inclusion and exclusion criteria and ocular features that might affect visual outcome were documented. Stereoscopic color fundus photography and fluorescein angiography were repeated 1 month after randomization for patients assigned to surgery to provide documentation that surgery was performed and to assess compliance with the surgery protocol. Photographs and fluorescein angiograms of both the study eye and the fellow eye in all patients then were obtained 3 months, 6 months, and 12 months after randomization and then annually up to 48 months. The kappa statistic was used to evaluate interobserver reliability of photograph gradings. Results Lesion components at baseline included classic CNV, occult CNV, and features contiguous to CNV, including blood, fibrous tissue, hypofluorescence not corresponding to blood, serous detachment of the retinal pigment epithelium, and prior areas of laser photocoagulation. At follow-up, fluorescein leakage from CNV was assessed peripheral to or within the area of the retinal pigment epithelium abnormality after surgery. The lesion at follow-up could include any of the features identified at baseline as well as retinal pigment epithelium abnormalities, such as mottling of the retinal pigment epithelium with a subtle transition to normal retinal pigment epithelium or a very sharply demarcated, markedly hypopigmented area that was easily distinguished from the surrounding retinal pigment epithelium. kappa statistics for interobserver reliability ranged from good (0.47) to excellent (1.00) for features graded at baseline and follow-up. Conclusions Although some of the definitions essential to the interpretation of the SST are similar to those used in the Macular Photocoagulation Study and randomized clinical trials of photodynamic therapy with verteporfin, this guideline provides new information regarding lesion components at baseline as well as standardized descriptions of lesions after submacular surgery. These descriptions from the SST assist in understanding what lesions were studied, when additional treatment was considered after surgery, and how anatomical results should be interpreted.

To compare the size of subfoveal lesions based on photographic documentation before and after submacular surgery of choroidal neovascularization (CNV) lesions.Subfoveal lesion sizes at baseline and month 3 follow-up visits for patients assigned to surgery in the Submacular Surgery Trials (SST) Pilot Study were assessed categorically using Macular Photocoagulation Study (MPS) disc area (DA) circles. The Submacular Surgery Trials Pilot Study groups reviewed were as follows: Group N (age-related macular degeneration [AMD]; lesion50% blood; classic CNV present; sizeor =9 MPS DAs); Group R (AMD; prior nonfoveal laser; classic CNV present; sizeor =9 MPS DAs); Group B (AMD; lesionor =50% blood); and Group H (ocular histoplasmosis syndrome or idiopathic; classic CNV present; sizeor =9 MPS DAs).Postoperative month 3 lesion size was at least 1 size category smaller than the preoperative lesion size in 6% (4/66) of Group N, 0 (0/31) of Group R, 6% (2/34) of Group H, and 45% (18/40) of Group B eyes. In Group H eyes, there was no size change in 50% (17/34), and enlargement was found in 44% (15/34). For eyes in Groups N and R, approximately one third remained stable (20/66, 30% and 12/31, 39%, respectively), whereas two thirds enlarged by at least 1 category (42/66, 64% and 19/31, 61%, respectively).The change in lesion size after submacular surgery was variable, with a tendency for Group H lesions to remain the same size or larger, Group B lesions to measure smaller, and Group N and Group R lesions to be larger.

PURPOSE To describe health-related quality of life (HRQOL), overall and in patients with unilateral or bilateral choroidal neovascularization (CNV), in a clinical trial (Group N Trial) comparing observation and surgical removal of subfoveal CNV secondary to age-related macular degeneration (AMD). DESIGN Randomized clinical trial. PARTICIPANTS Eligible patients had untreated subfoveal CNV and AMD, best-corrected visual acuity (VA) of 20/100 to 20/800, classic CNV on fluorescein angiography, and a total subfoveal lesion size of < or =9.0 disc areas in the study eye. METHODS Health-related quality of life data (the National Eye Institute Visual Function Questionnaire [NEI-VFQ], 36-item Short Form Health Survey [SF-36], and Hospital Anxiety and Depression Scale [HADS]) and clinical data were collected at baseline and at 6, 12, 24, 36, and 48 months. Patients were divided into unilateral and bilateral CNV subgroups based on fluorescein angiographic and clinical evidence. MAIN OUTCOME MEASURE Two-year change in the NEI-VFQ. RESULTS Of 454 patients enrolled, 228 were assigned to observation and 226 to surgery. At baseline, median overall NEI-VFQ scores were 67 in the observation group and 69 in the surgery group; by 2 years, the observation group had lost a median of 3 points (95% confidence interval [CI]: -6 to -2), and the surgery group gained a median of 1 point (CI: -1 to 3). The largest difference was observed for the mental health subscale, where the observation group lost a median of 5 points (CI: -5 to 0), and the surgery group gained a median of 5 points (CI: 0-10) by 2 years. Treatment differences in median 2-year changes in NEI-VFQ scores favored surgery by up to 10 points for unilateral cases and up to 8 points for bilateral cases. No treatment difference in 2-year change was observed for the SF-36 physical component summary; 2-year change in the mental component summary favored surgery by 2 points. Few patients (2%-4%) had HADS definite anxiety or depression at baseline or at 24 months. CONCLUSIONS Although HRQOL outcomes were better in the submacular surgery arm than in the observation arm, surgery (per protocol) is not recommended because VA outcomes (reported elsewhere) were similar in the treatment arms. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.

Purpose To present best-corrected visual acuity (BCVA) findings and other clinical outcomes from eyes of patients enrolled in one of the Submacular Surgery Trials (SST) evaluating surgical removal versus observation of predominantly hemorrhagic subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration. Design Randomized clinical trial (SST Group B Trial). Participants Eligible patients had subfoveal choroidal neovascular lesions greater than 3.5 disk areas (8.9 mm2) composed of at least 50% blood (either blood or CNV underlying the center of the foveal avascular zone) and BCVA of 20/100 to light perception in the study eye. Intervention Patients were assigned randomly at time of enrollment to observation or surgical removal of blood and any associated CNV. Main outcome measure A successful outcome was defined a priori as either improvement in visual acuity (VA), no change in VA, or a decline in VA of no more than 1 line (7 letters) from baseline to the 24-month examination based on an intent-to-treat analysis. Results Of 336 patients enrolled, 168 were assigned to each treatment arm; treatment arms were balanced by baseline characteristics. Of 1501 expected examinations 3 months through 36 months after baseline, 1370 (91%) were performed. Loss of > or =2 lines (> or =8 letters) of VA occurred in 56% of surgery eyes, versus 59% of observation eyes examined at 24 months. Although severe loss of VA was not the primary outcome of interest, surgery more often prevented such loss: 36% in the observation arm versus 21% in the surgery arm at the 24-month examination (chi2 P = 0.004). Of initially phakic eyes, the cumulative percentage that had undergone cataract surgery by 24 months was 44% in the surgery arm, compared with 6% in the observation arm. Twenty-seven eyes (16%) in the surgical arm, compared with 3 eyes (2%) in the observation arm, had a rhegmatogenous retinal detachment (RD). Conclusions Submacular surgery as performed in the SST Group B Trial did not increase the chance of stable or improved VA (the primary outcome of interest) and was associated with a high risk of rhegmatogenous RD, but did reduce the risk of severe VA loss in comparison with observation. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.

OBJECTIVE To report findings regarding health-related quality-of-life outcomes by treatment arm, both overall and within subgroups defined by selected baseline characteristics, among patients who participated in the Submacular Surgery Trials (SST) randomized trial of observation vs surgical removal of subfoveal choroidal neovascular lesions that were either idiopathic or associated with ocular histoplasmosis (SST Group H Trial). DESIGN AND METHODS Eligible patients were 18 years or older and had subfoveal choroidal neovascularization (including a classic component on fluorescein angiography) and visual acuity of 20/50 to 20/800 inclusive in the eye randomly assigned to surgery or observation. Trained interviewers, who were masked to treatment assignment, administered the National Eye Institute Visual Function Questionnaire (NEI-VFQ), the 36-Item Short-Form Health Survey (SF-36), and the Hospital Anxiety and Depression Scale (HADS) by telephone before enrollment and at 6, 12, and 24 months after enrollment; early enrollees also had interviews at 36 and 48 months. Baseline clinical examinations provided data regarding visual acuity, other aspects of vision, and presence of unilateral or bilateral choroidal neovascularization. RESULTS Of 225 patients interviewed at baseline and enrolled, 201, 190, and 161 patients (respectively, 89%, 85%, and 88% of those eligible to be interviewed) were interviewed 12, 24, and 36 months later. The NEI-VFQ scores in both treatment arms improved from baseline (median score, 75) to the 24-month interview. Patients in the surgery arm had 4-point larger improvements, on average, than patients in the observation arm (95% confidence interval, 1-8 points). The largest differences between treatment arms for mean 24-month improvements from baseline were in the role difficulties subscale (9 points) and dependency subscale (8 points), with larger mean improvements in the surgery arm. Scores on the SF-36 worsened by approximately 1 point on the physical component summary and improved by 2 points or more on the mental component summary in both treatment arms by 24 months in comparison to baseline. The percentage of HADS-defined "definite cases" of both anxiety and depression declined from baseline in each treatment arm. CONCLUSIONS Vision-targeted quality of life improved more after submacular surgery than with observation, supporting a possible small overall benefit of surgery suggested by the ophthalmic outcomes reported elsewhere. Ophthalmologists and patients similar to those who participated in the SST Group H Trial should be aware of the effects of submacular surgery on specific aspects of vision-targeted quality of life as well as on ophthalmic outcomes when considering this treatment approach.

Purpose To describe the effect of subfoveal choroidal neovascularization (CNV) from age-related macular degeneration (AMD) on health-related quality of life (HRQOL) of patients at enrollment in two randomized clinical trials; to examine the relation of visual acuity to HRQOL; to compare HRQOL scores between participants with unilateral and bilateral CNV independent of other characteristics. Design Randomized clinical trials. Methods Two Submacular Surgery Trials (SST) recruited patients with AMD and either new subfoveal CNV (Group N Trial) or predominantly hemorrhagic CNV (Group B Trial). Health-related quality of life interviews included the National Eye Institute Visual Function Questionnaire [NEI-VFQ], the SF-36 Health Survey, and the Hospital Anxiety and Depression Scale [HADS]. Linear correlation and regression analyses were used to relate baseline HRQOL scores to visual acuity and bilateral disease. Results Interview data were analyzed for 789 AMD patients: 454 patients in the Group N Trial and 335 patients in the Group B Trial. Participants reported poor vision-related functioning in many domains measured by the NEI-VFQ (mean overall scores of 65 for Group N and 63 for Group B). Visual acuity of the better eye was strongly associated with NEI-VFQ scores but not with SF-36 or HADS scores. After adjusting for visual acuity of the better eye and other factors, bilateral cases had NEI-VFQ overall scores six points lower than unilateral cases in Group N Trial and 10 points lower than unilateral cases in the Group B Trial. Conclusions Subfoveal CNV profoundly affects vision-related quality of life. The effect is more pronounced with bilateral disease, even after controlling for visual acuity.

To describe time trends, from 1987 through 1997, (1) in size of choroidal melanoma among patients with recent diagnosis confirmed at a clinical center that participated in the Collaborative Ocular Melanoma Study (COMS) and (2) in choice of treatment by patients who did not enroll in one of the COMS randomized trials.Investigators at all COMS clinical centers (41 in the United States and 2 in Canada) agreed to report, in a masked fashion that did not include personal identifiers, all patients diagnosed as having choroidal melanoma during the accrual period for COMS randomized trials of radiotherapy. Information reported for patients who did not enroll in a COMS randomized trial included tumor dimensions, date of diagnosis, and initial treatment selected. Patients reported by centers that continued to report cases until 1997 and diagnosed as having choroidal melanoma no more than 1 year before evaluation at a participating COMS center contributed the data analyzed.Time trends in tumor size among patients reported and in elective treatment of patients not enrolled in COMS randomized trials.Of 8712 patients with choroidal melanoma examined, 6703 met criteria for analysis of time trend in tumor size and 4077 were analyzed for treatment trends over time. The number of cases with longest tumor basal diameter greater than 15.0 mm declined over time from 393 (30%) of 1330 cases reported in 1987 through 1989 to 345 (25%) of 1397 cases reported in 1996 or 1997. The proportion of patients eligible for COMS randomized trials who did not enroll and who elected enucleation remained stable over time for tumors of all sizes; the proportion of these patients who elected eye-conserving radiotherapy increased over time. Juxtapapillary tumors accounted for nearly half of the enucleations among ineligible patients who had tumors no larger than 15.0 mm in longest basal diameter.Among patients examined at COMS centers during 1987 through 1997, the trends observed for patients with recently diagnosed choroidal melanoma included increasing presentation with tumors of smaller size, decreasing use of enucleation for choroidal melanoma 15.0 mm or less in longest basal diameter, and increasing use of such strategies for larger tumors.

The aim of this study was to determine the prognostic significance of a previously published system for classifying mechanical injuries of the eye (globe) in open-globe injuries.The medical records of 150 patients with open-globe injuries identified from an established institutional database were retrospectively reviewed to classify all injuries at presentation by the four specific variables of the classification system: type of injury, defined by the mechanism of injury; grade of injury, defined by visual acuity in the injured eye at initial examination; pupil, defined as the presence or absence of a relative afferent pupillary defect in the injured eye; and zone of injury, defined by the location of the eye-wall opening. Final visual outcomes for these injuries were also recorded. Logistic regression models were used to analyze the data and to determine whether relationships existed between the specific classification variables and final visual acuity in the injured eyes.All four classification variables were significant predictors of visual outcome. When adjusted for the other variables, grade and pupil were the most significant predictors of final visual acuity.This system for classifying mechanical injuries of the eye appears to be prognostic for visual outcomes in open-globe injuries. In particular, the measurement of visual acuity and testing for a relative afferent pupillary defect at the initial examination should be performed in all injured eyes because of their relative prognostic significance.

PURPOSE To compare the efficacy of one intraoperative dose of intravenous ketorolac tromethamine to saline placebo in controlling postoperative eye pain, nausea, and sedation following vitreoretinal surgery. STUDY DESIGN Prospective, randomized, placebo-controlled clinical trial. METHODS One hundred fourteen vitreoretinal surgical patients were randomized over a 7-month period to a single intraoperative intravenous dose of ketorolac tromethamine or placebo. All patients underwent surgery with intravenous sedation and retrobulbar anesthetic injection and had access to a standard postoperative analgesic regimen. After 2 and 5 hours, eye pain, nausea, and sedation levels were recorded using a standard visual analog scale. Analgesic requirements were tabulated. RESULTS Patients given ketorolac were significantly less likely to have postoperative eye pain than were placebo-treated patients (P = 0.0043). Fewer ketorolac patients required postoperative analgesia than placebo patients did (P < 0.0001). Four ketorolac patients (7%) required a narcotic compared to 11 placebo patients (20%) (P < 0.0001). Fewer ketorolac patients experienced nausea and sedation than placebo patients did, but this difference was not statistically significant. CONCLUSION Ketorolac tromethamine is an effective nonnarcotic choice for postoperative pain control following vitreoretinal surgery. Pain control is particularly important in this group of patients, whose compliance with postoperative procedures and positioning may significantly affect surgical outcome.

Purpose: To study the outcome of open globe injuries In patients aged Methods: Between January 1970 and January 1993, 180 eyes of children who presented with an open globe injury were retrospectively analyzed. Patients were divided into two groups. One group of children underwent treatment of an open globe injury between January 1970 and December 1981 (group A) and another between December 1985 and January 1993 (group B). Main outcome measures studied were final visual acuity and enucleation rates. Risk factors studied included age, race, sex, visual acuity, type of trauma, and various injury characteristics at presentation. Results: The factors associated with visual outcomes included: age, type of injury, wound size, initial visual acuity, and retinal detachment. Final visual outcome and enucleation rates were not significantly different between the older series (group A) and the recent series (group B). Lenticular damage, location, posterior extent of the injury, and presence of an intraocular foreign body had been significant prognostic factors in the older series, but were not statistically associated with the prognosis in the recent series. Conclusion: The nature of the injury and the patient's age are the main determining factors in the outcome of open globe injuries in children. Journal of Pediatric Ophthalmology and Strabismus 2001;38:72-77.

Purpose: Submacular surgery is under investigation for the treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration, ocular histoplasmosis syndrome, and other causes. The aims of this study were to determine whether the macular area from which choroidal neovascularization was removed surgically remained functional and whether there was any qualitative difference between eyes with different disease conditions or between eyes of younger and older patients. Methods: Our study included 19 patients (19 eyes) with choroidal neovascularization, seven cases caused by age-related macular degeneration and 12 caused by ocular histoplasmosis syndrome, pathologic myopia, or idiopathic causes. All tests were performed at least 6 months after surgical removal of choroidal neovascularization. All patients underwent fundus perimetry with the scanning laser ophthalmoscope for evaluation of dense and relative scotomas and fixation site. Results: After submacular surgery in 19 patients, 10 patients (one with age-related macular degeneration and nine with pathologic myopia, ocular histoplasmosis syndrome, or an idiopathic cause of choroidal neovascularization) fixated within an area that ophthalmoscopically and angiographically was an area of retinal pigment epithelial disturbance occupied by choroidal neovascularization preoperatively. Of 12 patients without age-related macular degeneration, seven of eight patients younger than 50 years of age compared with two of four patients 50 years or older fixated within the area of retinal pigment epithelial disturbance. Conclusions: Our data suggest that in patients without age-related macular degeneration who undergo submacular surgery, the surgically disturbed area previously occupied by choroidal neovascularization can remain functional postoperatively. Furthermore, occasionally a patient with age-related macular degeneration undergoing submacular surgery still can fixate in the area from which the choroidal neovascularization was removed.

AIMS/BACKGROUND This investigation determined eye care utilisation patterns in a rural county in Ireland. Population based estimates of visual impairment and glaucoma were available, so the two studies will optimise planning for eye care services for the county. METHODS Roscommon has a population of 55 000 served by one ophthalmologist and two optometrists. Data were collected on all outpatient visits for all providers for a 3 month period. Information was abstracted on demographics, presenting and final diagnoses. Expected number of visits for glaucoma were calculated using the population structure and rates of glaucoma, and assuming one visit per year per glaucoma patient. RESULTS 1398 patients had a total of 1442 visits in 3 months. A third of the visits were to optometrists, and all but 21 visits were for normal eye examinations or glasses. The majority of children aged less than 16 years, and people older than 60 years were seen by the ophthalmologist. Among children, 81% of all visits were to the ophthalmologist and 92% were classified as a normal examination. Only an estimated 188 visits per year for glaucoma were observed, compared with 1100 expected. CONCLUSION In this rural county, many of the visits to the ophthalmologist were for normal eye examination, particularly among children. Screening algorithms which would free the ophthalmologist to see more complicated problems could be considered. There is an underutilisation of services by glaucoma patients. Reasons for this are described.

Purpose: Geographic atrophy (GA) may cause significant compromise of visual function, even when there still is good visual acuity (VA), because of parafoveal scotomas and foveal function abnormalities antedating visible atrophy. This study evaluates the visual function abnormalities at baseline and the 2-year worsening of VA and reading rate for eyes with GA compared with a group of eyes with drusen only. Methods: Seventy-four eyes with GA and VA greater than or equal to 20/50 from a prospective natural history study of GA were included, as were 13 eyes with only drusen. Baseline visual function testing and 2-year VA and maximum reading rate are reported. Results: The worsening of VA in decreased luminance and foveal dark-adapted sensitivity showed severe abnormalities for the GA group. Contrast sensitivity was significantly reduced for the eyes with GA. Half the eyes with GA, but none of the drusen eyes, had maximum reading rates below 100 words per minute. A scanning laser ophthalmoscope (SLO) measure of the scotoma near fixation combined with a measure of residual foveal function accounted for 54% of the variability in maximum reading rate in the eyes with GA. Of 40 eyes with GA observed for 2 years, half lost greater than or equal to 3 lines of VA and one quarter lost greater than or equal to 6 lines. The nine eyes with drusen with follow-up had no significant change in VA. Low foveal dark-adapted sensitivity, SLO measures of the scotoma within 1° of fixation, and low maximum reading rate were statistically significant risk factors for doubling of the visual angle. Significant reduction in maximum reading rates at 2 years was present for the eyes with GA. Conclusions: The eyes with GA with good VA have profound decreases in visual function, particularly in dim lighting and in reading. Half the eyes with GA had doubling in visual angle at 2 years after the baseline examination, whereas the drusen eyes remained essentially unchanged. Impaired visual function at baseline was predictive of an adverse outcome for the eyes with GA.

The benefit of laser photocoagulation to choroidal neovascularization secondary to angioid streaks remains controversial. To further expand our knowledge, we reviewed the records of 20 patients (24 eyes) with classic (well-defined) choroidal neovascularization secondary to angioid streaks, who were treated with laser between 1982 and 1991 at the Retinal Vascular Center of the Wilmer Institute. The choroidal neovascularization was extrafoveal in 18 (75%), juxtafoveal in two, subfoveal in three, and indeterminate in one eye. Seventeen of the 24 fellow eyes (71%) had a disciform scar or choroidal neovascularization, or both. Follow-up ranged from three months to nine years (mean, 3.5 years; median, two years). Lines of visual acuity change averaged -2.5 at three, -2.6 at six, -2.4 at 12, and -4.8 lines at 24 months. Choroidal neovascularization persisted in five of 24 eyes and recurred in nine of the remaining 19 eyes at risk. When the fellow eye had choroidal neovascularization, scar, or both, at the time of treatment, the rate of persistence or recurrence was 65% vs 33% if the fellow eye had no choroidal neovascularization, scar, or both. An average of four lines of visual acuity was lost when fellow eyes had choroidal neovascularization, scar, or both, vs one line when the fellow eye had no choroidal neovascularization or scar. Laser photocoagulation of choroidal neovascularization in patients with angioid streaks can result in closure of the choroidal neovascularization and stabilization of visual acuity.

PURPOSE To present and compare findings from health-related quality-of-life (HRQOL) interviews conducted with patients enrolled in the SST Group B Trial evaluating surgical removal of subfoveal choroidal neovascular lesions associated with age-related macular degeneration versus observation. DESIGN Randomized clinical trial. PARTICIPANTS Eligible patients had predominantly hemorrhagic subfoveal choroidal neovascular lesions (total lesion size of >3.5 disc areas, area of blood at least 50% of the lesion area, and at least 75% of blood posterior to the equator) and best-corrected visual acuity (VA) of 20/100 to

Objective To present visual acuity findings and related outcomes from eyes of patients enrolled in a randomized trial conducted by the Submacular Surgery Trials (SST) Research Group (SST Group H Trial) to compare surgical removal vs observation of subfoveal choroidal neovascular lesions that were either idiopathic or associated with ocular histoplasmosis. Methods Eligible patients 18 years or older had subfoveal choroidal neovascularization (new or recurrent) that included a classic component on fluorescein angiography and best-corrected visual acuity of 20/50 to 20/800 in 1 eye ("study eye"). Patients were examined 3, 6, 12, and 24 months after enrollment to assess study outcomes and adverse events. Best-corrected visual acuity was measured by a masked examiner at the 24-month examination. A successful outcome was defined a priori as 24-month visual acuity better or no more than 1 line (7 letters) worse than at baseline. Results Among 225 patients enrolled (median visual acuity 20/100), 113 study eyes were assigned to observation and 112 to surgery. Forty-six percent of the eyes in the observation arm and 55% in the surgery arm had a successful outcome (success ratio, 1.18; 95% confidence interval, 0.89-1.56). Median visual acuity at the 24-month examination was 20/250 among eyes in the observation arm and 20/160 for eyes in the surgery arm. The prespecified subgroup of eyes with visual acuity worse than 20/100 at baseline (n = 92) had more successes with surgery; 31 (76%) of 41 eyes in the surgery arm vs 20 (50%) of 40 eyes in the observation arm examined at 24 months (success ratio, 1.53; 95% confidence interval, 1.08-2.16). Five (4%) of 111 eyes in the surgery arm subsequently had a rhegmatogenous retinal detachment. Twenty-seven (24%) of 112 initially phakic eyes in the surgery arm (none in the observation arm) had cataract surgery during follow-up, all among patients older than 50 years. Recurrent choroidal neovascularization developed by the 24-month examination in 58% of surgically treated eyes. Conclusions Overall, findings supported no benefit or a smaller benefit to surgery than the trial was designed to detect. Findings support consideration of surgery for eyes with subfoveal choroidal neovascularization and best-corrected visual acuity worse than 20/100 that meet other eligibility criteria for the SST Group H Trial. Other factors that may influence the treatment decision include the risks of retinal detachment, cataract among older patients, and recurrent choroidal neovascularization and the possibility that additional treatment will be required after submacular surgery.

OBJECTIVE To compare the performance of community- vs university-based clinical centers in 3 multicenter randomized clinical trials of intraocular surgery. METHODS Each Submacular Surgery Trials clinical center was classified as a university-based center, if the contract to perform as a center was signed by a university official, or as a community-based center. The 2 groups of centers were compared on performance, assessed cumulatively by the Submacular Surgery Trials Quality Assurance and Monitoring Subcommittee. OUTCOME MEASURES Patient accrual, completion of scheduled examinations, completion of masked vision examinations 2 years after enrollment (the designated primary study end point evaluation time), timeliness of submission of retinal photographs required by protocol to the Photograph Reading Center, completion of health- and vision-related quality-of-life interviews, and timeliness of submission of the primary outcome data to the Coordinating Center after completion of the examination. RESULTS Almost all centers performed at a very high (good) level, although there was a trend for some community-based centers to be at the lower end of most distributions. CONCLUSIONS Most community- and university-based centers performed well in these multicenter clinical trials. Monitoring performance and periodically providing feedback to clinical center investigators may encourage excellent performance in areas critical to the success of clinical trials, regardless of whether the center is community or university based.

BACKGROUND The National Eye Institute Visual Function Questionnaire (NEI-VFQ) measures vision-targeted quality of life, but it is unclear whether it is sensitive to changes within individuals over time. OBJECTIVE To determine the responsiveness of the NEI-VFQ to "within-individual" changes in visual acuity in patients who had subfoveal choroidal neovascularization in at least one eye secondary to age-related macular degeneration, ocular histoplasmosis syndrome, or idiopathic causes, and who participated in randomized trials of submacular surgery. METHODS Trained telephone interviewers administered the NEI-VFQ as part of annual follow-up data collection for pilot trials and larger clinical trials of submacular surgery. Best-corrected visual acuity was measured by local vision examiners at 12 months after enrollment and, typically, by central "traveling" vision examiners at 24 months after enrollment. Changes in visual acuity and NEI-VFQ scores from 12 to 24 months were analyzed using linear regression methods. RESULTS Two-hundred eighteen patients had both interviews and visual acuity measurements at 12 and 24 months after enrollment. Changes in the overall NEI-VFQ score and in 9 of the subscales (near activities, dependency, driving, role difficulties, distance activities, mental health, general vision, peripheral vision, and social functioning) were related to changes in visual acuity of the better-seeing eye based on linear regression analysis (P

Purpose To ascertain the importance of routine cultures and gram stains in the management of ulcerative keratitis. Methods We retrospectively reviewed 119 consecutive corneal ulcers seen at Sinai Hospital of Baltimore. Cultures were obtained of the corneal ulcer and of the lids and conjunctivae of both eyes. Gram stains were performed by the hospital microbiology department on corneal scrapings from each ulcer. Results Positive corneal cultures were obtained from 56 eyes (47.1%). Initial antibiotic therapy was changed based on culture results in 14.3% of culture-positive eyes that demonstrated a worsening clinical course. Gram stains were negative in all cases. The sensitivity and specificity of the lid and conjunctival cultures were determined. Conclusions Corneal cultures are important in the management of ulcerative keratitis. Lid and conjunctival cultures have low sensitivity and specificity.

Objective: To determine the extent of preservation in the inner retina in retinitis pigmentosa (RP). Methods: We analyzed sectioned maculae of 21 postmortem eyes with RP and 19 age-matched, normal, postmortem eyes. Eyes were divided into 2 groups: severe and moderate RP. Cell nuclei were counted in the outer nuclear, inner nuclear, and ganglion cell layers within thirty 100-μm intervals from the foveola to 1500-μm eccentricity. Results: Statistically significant (P≤.05) loss of both the outer nuclear and ganglion cell layers was present in the groups with moderate and severe RP when compared with the control groups. However, even in the group with severe RP, 30% of the ganglion cells were histologically intact. Similarly, 78% and 88% of the inner nuclear layer cells were preserved in the groups with severe and moderate RP, respectively. Different inheritance modes showed no statistically significant differences in any of the retinal layers. Conclusions: Despite a statistically significant (P≤.05) loss of cells found in all retinal layers, a large percentage of the inner retinal neurons remained histologically intact. Current experimental therapies, such as photoreceptor transplantation and implantation of a visual prosthesis, are based on the premise that some inner retinal neurons are preserved after death of photoreceptors in RP. Our observations support this assumption.