Reproducibility of gradings of retinal photographs in eyes with subfoveal choroidal neovascularization and age-related macular degeneration in the macular photocoagulation study.

Purpose: To assess the reproducibility of the evaluation of color photographs and fluorescein angiograms of the macula of each eye for patients enrolled in the Macular Photocoagulation Study (MPS) trials of laser photocoagulation of subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration.

Methods: A total of 65 pre-enrollment and 26 posttreatment sets of photographs were regraded. The two gradings were compared on selected items judged to be of primary importance with respect to the role of the MPS Reading Center.

A method of reporting macular edema after cataract surgery using optical coherence tomography.

Objective: To validate a method of reporting postcataract macular edema (ME) using optical coherence tomography (OCT).

Methods: : Data were analyzed for 130 eyes followed prospectively for ME after uncomplicated cataract surgery. Each eye underwent OCT within 4 weeks before surgery and at 1 month and 3 months after surgery.

Low luminance visual dysfunction as a predictor of subsequent visual acuity loss from geographic atrophy in age-related macular degeneration.

Objective: To show that low luminance visual dysfunction is predictive of subsequent visual acuity (VA) loss in eyes with geographic atrophy (GA) resulting from age-related macular degeneration (AMD).

Design: Cohort study examining the prospective natural history study of GA from 1992 through 2000 at the Wilmer Eye Institute.

Participants: Ninety-one participants with GA resulting from AMD without choroidal neovascularization in at least 1 eye who completed a 2-year study examination.

Comparison of time-domain OCT and fundus photographic assessments of retinal thickening in eyes with diabetic macular edema.

Purpose: To explore the correlation between optical coherence tomography (OCT) and stereoscopic fundus photographs (FP) for the assessment of retinal thickening (RT) in diabetic macular edema (DME) within a clinical trial.

Methods: OCT, FP, and best corrected visual acuity (VA) measurements were obtained in both eyes of 263 participants in a trial comparing two photocoagulation techniques for DME. Correlation coefficients (r) were calculated comparing RT measured by OCT, RT estimated from FP, and VA.

Retinal thickness on Stratus optical coherence tomography in people with diabetes and minimal or no diabetic retinopathy.

Purpose: To evaluate optical coherence tomography (OCT) thickness of the macula in people with diabetes but minimal or no retinopathy and to compare these findings with published normative data in the literature from subjects reported to have no retinal disease.

Design: Cross-sectional study.

Methods: In a multicenter community- and university-based practices setting, 97 subjects with diabetes with no or minimal diabetic retinopathy and no central retinal thickening on clinical examination and a center point thickness of 225 microm or less on OCT (Stratus OCT; Carl Zeiss Meditec, Dublin, California, USA) were recruited.

Agreement between clinician and reading center gradings of diabetic retinopathy severity level at baseline in a phase 2 study of intravitreal bevacizumab for diabetic macular edema.

Purpose: To evaluate agreement in diabetic retinopathy severity classification by retina specialists performing ophthalmoscopy versus reading center (RC) grading of seven-field stereoscopic fundus photographs in a phase 2 clinical trial of intravitreal bevacizumab for center-involved diabetic macular edema.

Methods: Clinicians' grading scale used four levels: microaneurysms only, mild/moderate nonproliferative diabetic retinopathy (NPDR), severe NPDR, and proliferative diabetic retinopathy (PDR) or prior panretinal photocoagulation (PRP) or both. The RC scale used eight levels: microaneurysms only, mild NPDR, moderate NPDR, moderately severe NPDR, severe NPDR, mild PDR, moderate PDR, and high-risk PDR.

Vitamin usage patterns in the prevention of advanced age-related macular degeneration.

Objective: To describe micronutrient usage patterns among patients at a tertiary ophthalmic center.

Design: Cross-sectional clinical case series.

Participants: Three hundred thirty-two adult patients with a diagnosis of age-related macular degeneration (AMD).

Verteporfin therapy of subfoveal occult choroidal neovascularization in AMD using delayed light application: one-year results of the VALIO Study.

Purpose: To compare photodynamic therapy (PDT) with verteporfin (Visudyne; Novartis Pharma AG, Basel, Switzerland) using either standard or delayed light application.

Design: Phase II, multicenter, masked, randomized clinical trial.

Methods: Sixty patients with occult with no classic choroidal neovascularization (CNV) resulting from age-related macular degeneration were assigned randomly (1:1) to verteporfin infusion followed by light application either at 15 minutes (standard light) or 30 minutes (delayed light) after the start of the infusion.

Improved vision-related function after ranibizumab treatment of neovascular age-related macular degeneration: results of a randomized clinical trial.

Objective: To examine the effects of ranibizumab on patient-reported visual function using the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) in patients with neovascular age-related macular degeneration (AMD).

Design: In MARINA, a randomized, double-masked clinical trial, 716 patients with AMD with recent disease progression and minimally classic or occult with no classic lesion component were randomized 1:1:1 to monthly intravitreal ranibizumab (0.3 or 0.

Incident choroidal neovascularization in fellow eyes of patients with unilateral subfoveal choroidal neovascularization secondary to age-related macular degeneration: SST report No. 20 from the Submacular Surgery Trials Research Group.

Objective: To describe incident choroidal neovascular lesions in fellow eyes of participants in the Submacular Surgery Trials who had age-related macular degeneration (AMD).

Methods: Review of baseline fluorescein angiograms confirmed the absence of neovascular AMD in fellow eyes of 364 participants at risk. Subjects were eligible for a minimum of 2 years of follow-up with angiograms of eyes at risk reevaluated to estimate incidence rates of choroidal neovascularization (CNV) and to characterize these lesions.

Visual acuity as an outcome measure in clinical trials of retinal diseases.

Purpose: Visual acuity (VA) is the primary outcome measure in many studies involving eye diseases. A standard statistical approach for comparing a continuous measurement such as a VA letter score between 2 treatment groups is to perform a t test comparing the means. However, frequently a binary variable is created from the continuous VA letter score based on whether or not there has been a worsening (or gain) of > or =15 letters (equivalent to > or =3 lines), and a chi square or similar statistical test is performed to compare the proportions of success (or failure) between groups.

Periocular triamcinolone and photodynamic therapy for subfoveal choroidal neovascularization in age-related macular degeneration.

Purpose: To evaluate fluorescein angiographic and visual acuity (VA) outcomes from patients enrolled in a trial of a single periocular corticosteroid injection immediately before photodynamic therapy (PDT) versus PDT alone for subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Design: Randomized 2-center clinical trial.

Participants: Sixty-seven subjects with AMD, subfoveal choroidal neovascularization, and best-corrected VA of 20/20 to 20/320 in the study eye who had received no more than 1 prior PDT treatment.

A phase II randomized clinical trial of intravitreal bevacizumab for diabetic macular edema.

Objective: To provide data on the short-term effect of intravitreal bevacizumab for diabetic macular edema (DME).

Design: Randomized phase II clinical trial.

Participants: One hundred twenty-one eyes of 121 subjects (109 eligible for analysis) with DME and Snellen acuity equivalent ranging from 20/32 to 20/320.

Patients' preferences in choosing therapy for retinal vein occlusions.

Purpose: The purpose of this study was to assess preference values for vein occlusions with macular edema and to determine how this may affect patient perceptions of potential treatments.

Methods: The Submacular Surgery Trials Vision Preference Value Scale and questions regarding enthusiasm for potential treatments were administered to 153 patients with vein occlusion. Univariate analyses identified predictors of preference values, followed by adjustment for potential confounders using multivariate linear regression.

Comparison of methods to identify incident cataract in eyes of patients with neovascular maculopathy: Submacular Surgery Trials Report No. 18.

Purpose: To describe and compare methods used to monitor development and progression of presumed vision-limiting lens opacity in study eyes of Submacular Surgery Trials (SST) patients.

Design: Prospective study of patients enrolled in a set of randomized clinical trials.

Participants: Patients enrolled in the SST who were phakic in the study eye at the time of enrollment (n = 690).

Reproducibility of macular thickness and volume using Zeiss optical coherence tomography in patients with diabetic macular edema.

Purpose: To evaluate optical coherence tomography (OCT) reproducibility in patients with diabetic macular edema (DME).

Design: Prospective 1-day observational study.

Participants: Two hundred twelve eyes of 107 patients with DME involving the macular center by clinical examination and OCT central subfield thickness of > or =225 microm.

Designing clinical trials for age-related geographic atrophy of the macula: enrollment data from the geographic atrophy natural history study.

Purpose: To derive information from the Geographic Atrophy (GA) Natural History Study that is relevant to recruiting patients and designing clinical trials for GA.

Methods: A prospective natural history study with annual follow-up enrolled patients with GA and no choroidal neovascularization (CNV) in at least one eye. Characteristics of recruited and enrolled patients are analyzed, in the context of progression data from the study.

Analysis of macular edema after cataract surgery in patients with diabetes using optical coherence tomography.

Objective: To assess the incidence or progression of macular edema (ME) after cataract surgery in diabetic patients using optical coherence tomography (OCT) and correlating this with degree of diabetic retinopathy or other risk factors.

Design: Prospective cohort study.

Participants: Fifty diabetic eyes undergoing cataract surgery.

The long-term natural history of geographic atrophy from age-related macular degeneration: enlargement of atrophy and implications for interventional clinical trials.

Purpose: To report the enlargement rate of geographic atrophy (GA) over time, its relationship to size of atrophy at baseline and to prior enlargement rate, and the implications for designing future treatment trials for GA.

Design: Prospective natural history study of GA resulting from age-related macular degeneration.

Participants: Two hundred twelve eyes of 131 patients were included in the analysis.

New therapies for neovascular age-related macular degeneration: critical appraisal of the current evidence.

During the past 20 years, several multicentre clinical trials have investigated different therapies for neovascular age-related macular degeneration (AMD). These landmark studies have provided the scientific community with powerful data regarding the ability of laser photocoagulation, verteporfin therapy, pegaptanib sodium and submacular surgery to treat particular choroidal neovascular lesion types. Accurate interpretation of data from these trials is essential to enable clinicians to make informed decisions about therapeutic interventions.

Relationship between optical coherence tomography-measured central retinal thickness and visual acuity in diabetic macular edema.

Objective: To compare optical coherence tomography (OCT)-measured retinal thickness and visual acuity in eyes with diabetic macular edema (DME) both before and after macular laser photocoagulation.

Design: Cross-sectional and longitudinal study.

Participants: Two hundred ten patients (251 eyes) with DME enrolled in a randomized clinical trial of laser techniques.

Occult with no classic subfoveal choroidal neovascular lesions in age-related macular degeneration: clinically relevant natural history information in larger lesions with good vision from the Verteporfin in Photodynamic Therapy (VIP) Trial: VIP Report No. 4.

Objective: To determine whether data from patients with age-related macular degeneration (AMD) assigned to the placebo group in the Verteporfin in Photodynamic Therapy (VIP) Trial provide a rationale for continuation or cessation of follow-up of individuals with subfoveal occult choroidal neovascularization (CNV) with no classic lesions, presumed recent disease progression, larger lesion size (>4 disc areas), and a higher level of visual acuity (approximate Snellen equivalent, > or =20/50 in the affected eye) in whom no treatment is given at initial examination.

Methods: In a prospective, noncomparative case series, angiograms of participants assigned to a placebo group who had occult with no classic lesion composition at baseline were reviewed to identify conversion to minimally classic (area of classic CNV >0% but <50% of the entire lesion area) or predominantly classic (area of classic CNV > or =50% of the entire lesion area) composition.

Results: Of the 114 patients with AMD assigned to the placebo group, 89 were judged to have occult with no classic lesion composition at baseline in the study eye when fluorescein angiograms were reviewed in late 2001 for this report.

Hemoglobin A1c awareness among patients receiving eye care at a tertiary ophthalmic center.

Purpose: To describe awareness of hemoglobin A1c (HbA1c) among patients receiving eye care at a tertiary ophthalmic center for diabetic eye disease.

Design: Prospective, nonrandomized clinical case series.

Methods: One hundred-fifty adult patients with diabetes mellitus (DM) examined between July and October of 2003 for diabetic retinopathy (DR) were surveyed about HbA1c knowledge.

Clinicopathologic studies of eyes that were obtained postmortem from four patients who were enrolled in the submacular surgery trials: SST Report No. 16.

Purpose: To compare the fundus photographic and fluorescein angiographic features with the histologic findings in eyes from patients enrolled in the Submacular Surgery Trials (SST).

Design: Clinical trials with clinicopathologic correlation.

Methods: Eyes that were obtained postmortem from patients who participated in the donor program were processed at the SST Pathology Center and examined histologically; the macular regions were reconstructed topographically with two-dimensional cartography.