Objective: To describe characteristics of participants in the Complications of Age-Related Macular Degeneration Prevention Trial (CAPT) at baseline and to investigate associations among visual function, fundus features, and vision-related quality of life.Design: Cross-sectional study.Participants: The 1052 participants in CAPT, a multicenter, randomized clinical trial. Eligibility criteria for CAPT included 10 large drusen and visual acuity greater than or equal to20/40 in each eye.Methods: At baseline, the visual acuity, contrast sensitivity, and critical print size for each eye were measured, color stereo photographs of the disc and macula of each eye were taken, and the 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) was self-administered. Graders from a central photograph reading center evaluated the photographs for drusen characteristics and focal hyperpigmentation. All procedures were performed using standardized protocols. Associations among characteristics were assessed by Spearman correlation coefficients and multiple linear regression.Results: Among CAPT participants at baseline, the mean age was 71.0 years, 60.6% were women, and 99.3% were white. The median visual acuity of the better eye was 20/20 and of the worse eye 20/25. In approximately one third of eyes, drusen covered greater than or equal to10% of the retina within 3000 mum of the foveal center, and 67.7% of eyes had focal hyperpigmentation. Drusen area and focal hyperpigmentation were weakly correlated (r = -0.08 to -0.18) with the measures of visual function. The measures of visual function were weakly associated with the NEI-VFQ-25 scores. An association of fundus features with NEI-VFQ-25 scores was not found.Conclusion: At baseline, CAPT participants had good visual function and several risk factors for progression to neovascular age-related macular degeneration. Scores on the NEI-VFQ-25 indicated that participants perceived some problems with their vision. Within this relatively homogeneous group of participants, measures of visual function were only weakly associated with the measures of vision-related quality of life. (C) 2004 by the American Academy of Ophthalmology.

Objective: Guidelines were developed based on best available scientific data as well as consensus of expert opinion in absence of controlled clinical trial data to: 1) assist ophthalmologists with selection of patients for whom photodynamic therapy with verteporfin, termed "verteporfin therapy," should be considered; and 2) offer suggestions regarding treatment, follow-up, and re-treatment.Methods: Consensus from roundtable of retina specialists who either participated in randomized clinical trials evaluating verteporfin therapy or had clinical experience with verteporfin therapy was based on results of these trials and expert opinion. Additional input and advice were received from representatives on behalf of the Macula Society, the Retina Society, and the Vitreous Society, as well as principal investigators of randomized clinical trials evaluating verteporfin therapy.Results: Patient selection criteria included the following: 1) in cases due to age-related macular degeneration (AMD), lesion composition either predominantly classic choroidal neovascularization (CNV) or occult with no classic CNV; 2) CNV location subfoveal or so close to the foveal center that conventional laser photocoagulation treatment almost certainly would extend under the center; 3) lesion etiology from AMD, pathologic myopia, or other causes in which the outcome without treatment is likely to be worse than with treatment; 4) vision at a level where further loss would be recognized as detrimental to the quality of life of the patient. Criteria did not include lesion size, except in cases composed of occult with no classic CNV in AMD in which therapy for lesions >4 Macular Photocoagulation Study (MPS) disc areas usually should be considered only when presenting with lower levels of best-corrected visual acuity. Criteria also did not include patient age, history of systemic arterial hypertension, or prior laser photocoagulation. Therapy should occur ideally within 1 week of the initial fluorescein angiogram on which the clinical decision to treat is based. Patients should return for follow-up at least as often as every 3 months after any initial or subsequent treatment to determine if there is fluorescein leakage from CNV. Re-treatment should be considered as often as every 3 months if fluorescein leakage from CNV is noted at that time. Re-treatment could be deferred if the biomicroscopic and fluorescein angiographic appearance of the lesion is unchanged and shows minimal leakage, especially when there is no subretinal fluid or fluorescein leakage from CNV underlying the center of the foveal avascular zone. Patients should avoid exposure of skin or eyes to direct sunlight or bright indoor light for 48 hours after treatment or until resolution of any swelling or discoloration from extravasation.Conclusion: These recommendations provide guidelines on the role of verteporfin therapy in the management of CNV due to AMD and other causes. Revisions of these guidelines may be required as new data become available.

Background: Observational and experimental data suggest that antioxidant and/or zinc supplements may delay progression of age-related macular degeneration (AMD) and vision loss.Objective: To evaluate the effect of high-dose vitamins C and E, beta carotene, and zinc supplements on AMD progression and visual acuity.Design: The Age-Related Eye Disease Study, an 11-center double-masked clinical trial, enrolled participants in an AMD trial if they had extensive small drusen, intermediate drusen, large drusen, noncentral geographic atrophy, or pigment abnormalities in 1 or both eyes, or advanced AMD or vision loss due to AMD in 1 eye. At least 1 eye had best-corrected visual acuity of 20/32 or better. Participants were randomly assigned to receive daily oral tablets containing: (1) antioxidants (vitamin C, 500 mg; vitamin E, 400 IU; and beta carotene, 15 mg) (2) zinc, 80 mg, as zinc oxide and copper, 2 mg, as cupric oxide; (3) antioxidants plus zinc; or (4) placebo. Main Outcome Measures: (1)Photographic assessment of progression to or treatment for advanced AMD and (2) at least moderate visual acuity loss from baseline ( : 15 letters). Primary analyses used repeated-measures logistic regression with a significance level of .01, unadjusted for covariates. Serum level measurements, medical histories, and mortality rates were used for safety monitoring.Results: Average follow-up of the 3640 enrolled study participants, aged 55-80 years, was 6.3 years, with 2.4% lost to follow-up. Comparison with placebo demonstrated a statistically significant odds reduction for the development of advanced AMD with antioxidants plus zinc (odds ratio [OR], 0.72; 99% confidence interval [CI], 0.52-0.98). The ORs for zinc alone and antioxidants alone are 0.75 (99% CI, 0.55-1.03) and 0.80 (99% CI, 0.59-1.09), respectively. Participants with extensive small drusen, nonextensive intermediate size drusen, or pigment abnormalities had only a 1.3% 5-year probability of progression to advanced AMD. Odds reduction estimates increased when these 1063 participants were excluded (antioxidants plus zinc: OR, 0.66; 99% CI, 0.47-0.91; zinc: OR, 0.71; 99% CI, 0.52-0.99; antioxidants: OR, 0.76; 99% CI, 0.55-1.05). Both zinc and antioxidants plus zinc significantly reduced the odds of developing advanced AMD in this higher-risk group. The only statistically significant reduction in rates of at least moderate visual acuity loss occurred in persons assigned to receive antioxidants plus zinc (OR, 0.73; 99% CI, 0.54-0.99). No statistically significant serious adverse effect was associated with any of the formulations.Conclusions: Persons older than 55 years should have dilated eye examinations to determine their risk of developing advanced AMD. Those with extensive intermediate size drusen, at least 1 large druse, noncentral geographic atrophy in 1 or both eyes, or advanced AMD or vision loss due to AMD in 1 eye, and without contraindications such as smoking, should consider taking a supplement of antioxidants plus zinc such as that used in this study.

BACKGROUND Experimental and observational data suggest that micronutrients with antioxidant capabilities may retard the development of age-related cataract. OBJECTIVE To evaluate the effect of a high-dose antioxidant formulation on the development and progression of age-related lens opacities and visual acuity loss. DESIGN The 11-center Age-Related Eye Disease Study (AREDS) was a double-masked clinical trial. Participants were randomly assigned to receive daily oral tablets containing either antioxidants (vitamin C, 500 mg; vitamin E, 400 IU; and beta carotene, 15 mg) or no antioxidants. Participants with more than a few small drusen were also randomly assigned to receive tablets with or without zinc (80 mg of zinc as zinc oxide) and copper (2 mg of copper as cupric oxide) as part of the age-related macular degeneration trial. Baseline and annual (starting at year 2) lens photographs were graded at a reading center for the severity of lens opacities using the AREDS cataract grading scale. MAIN OUTCOME MEASURES Primary outcomes were (1) an increase from baseline in nuclear, cortical, or posterior subcapsular opacity grades or cataract surgery, and (2) at least moderate visual acuity loss from baseline (>/=15 letters). Primary analyses used repeated-measures logistic regression with a statistical significance level of P =.01. Serum level measurements, medical histories, and mortality rates were used for safety monitoring. RESULTS Of 4757 participants enrolled, 4629 who were aged from 55 to 80 years had at least 1 natural lens present and were followed up for an average of 6.3 years. No statistically significant effect of the antioxidant formulation was seen on the development or progression of age-related lens opacities (odds ratio = 0.97, P =.55). There was also no statistically significant effect of treatment in reducing the risk of progression for any of the 3 lens opacity types or for cataract surgery. For the 1117 participants with no age-related macular degeneration at baseline, no statistically significant difference was noted between treatment groups for at least moderate visual acuity loss. No statistically significant serious adverse effect was associated with treatment. CONCLUSION Use of a high-dose formulation of vitamin C, vitamin E, and beta carotene in a relatively well-nourished older adult cohort had no apparent effect on the 7-year risk of development or progression of age-related lens opacities or visual acuity loss.

Objective: To describe the clinical characteristics and survival experience of a prospectively followed up group of patients with small choroidal melanoma.Methods: The Collaborative Ocular Melanoma Study (COMS) is a set. of clinical trials designed to compare the role of radiotherapy and enucleation in the treatment of medium and large-size choroidal melanoma. From December 1986 to August 1989, patients with small choroidal melanoma, not large enough to be eligible for the COMS clinical trials, were offered participation in a nonrandomized prospective follow-up study. Small choroidal melanomas were defined as 1.0 to 3.0 mm in apical height and al least 5.0 mm in basal diameter. A total of 204 patients were enrolled in the study. Patients were followed up annually through August 1989. Two additional assessments of treatment status and mortality were conducted in 1993-1994 and 1995-1996. The median length of follow-up was 92 months. Eight percent of patients were treated at the time of study enrollment and an additional 33% were treated during follow-up.Results: Twenty-seven patients have died; 6 deaths were reported by the clinical center as due to metastatic melanoma. The Kaplan-Meier estimate of 5-year all-cause mortality was 6.0% (95% confidence interval, 2.7%-9.3%) and 8-year all-cause mortality was 14.9% (95% confidence interval, 9.6%-20.2%).Conclusions: Otherwise healthy patients, average age of GO years, without a previous diagnosis of malignant disease who have small choroidal lesions judged to be melanoma have a low risk of dying within 5 years.

Background: Interferon alfa-2a has been shown to be effective as an antiangiogenic agent for several systemic human angiogenic disorders and has shown antiangiogenic activity in the laboratory.Objective: To evaluate the safety and efficacy of interferon alfa-2a for the treatment of choroidal neovascularization secondary to age-related macular degeneration.Methods: A randomized, placebo-controlled, parallel, multicenter double-blind trial was performed at 45 ophthalmic centers worldwide. Four hundred eighty-one patients were randomly assigned to 4 treatment groups: placebo or or interferon alfa-2a (Roferon-A), 1.5, 3.0, or 6.0 million international units (MIU). Visual acuity testing, clinical examination, fluorescein angiography, and indocyanine green angiography were evaluated, with the primary end point being a comparison of the number of patients who experienced a loss of 3 lines or more of vision at 1 year.Results: At 52 weeks, 40 (38%; 95% confidence interval, 29%-48%) of 105 placebo-treated patients had lost at least 3 lines of vision (with 12% unavailable for follow-up), compared with 142 (50%; 95% confidence interval, 44%-55%) of 286 in che 3 active treatment groups combined. The difference in proportions was not statistically significant. However, a pairwise comparison of these proportions for the placebo group vs the group that received interferon alfa-2a, 6 MIU (with 26% unavailable for follow-up), showed a statistically significant difference in favor of the placebo group (P=.02) and a nearly significant difference for the placebo vs the 1.5-MIU group (P=.05) (with 16% unavailable for follow-up), again favoring the placebo group. The 3-MIU group (with 22% unavailable for follow-up) did not show a statistically significant difference in pairwise comparison (P=.48), suggesting that a dose-response relationship was not evident.Conclusion: Interferon alfa-2a provides no benefit as a treatment for choroidal neovascularization secondary to age-related macular degeneration and may be associated with a poorer visual outcome when given at a dose of 6 MIU. However, the absence of a clear dose-response relationship raises the possibility that the observed differences result from chance.