Screening for amblyopia in preverbal children with photoscreening photographs: IV. Interobserver variability in photograph grading: origin and method of reduction.

Background: 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.

Evaluation of the traveling vision examiner program in the submacular surgery trials pilot study.

Purpose: 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.

Methods: 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.

Guidelines for interpreting retinal photographs and coding findings in the Submacular Surgery Trials (SST): SST report no. 8.

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.

Changes in lesion size after submacular surgery for subfoveal choroidal neovascularization in the submacular surgery trials pilot study.

Purpose: To compare the size of subfoveal lesions based on photographic documentation before and after submacular surgery of choroidal neovascularization (CNV) lesions.

Methods: 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]; lesion <50% blood; classic CNV present; size < or =9 MPS DAs); Group R (AMD; prior nonfoveal laser; classic CNV present; size < or =9 MPS DAs); Group B (AMD; lesion > or =50% blood); and Group H (ocular histoplasmosis syndrome or idiopathic; classic CNV present; size < or =9 MPS DAs).

Surgical removal vs observation for subfoveal choroidal neovascularization, either associated with the ocular histoplasmosis syndrome or idiopathic: II. Quality-of-life findings from a randomized clinical trial: SST Group H Trial: SST Report No. 10.

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.

Surgical removal vs observation for subfoveal choroidal neovascularization, either associated with the ocular histoplasmosis syndrome or idiopathic: I. Ophthalmic findings from a randomized clinical trial: Submacular Surgery Trials (SST) Group H Trial: SST Report No. 9.

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.

Surgery for hemorrhagic choroidal neovascular lesions of age-related macular degeneration: quality-of-life findings: SST report no. 14.

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.

Surgery for hemorrhagic choroidal neovascular lesions of age-related macular degeneration: ophthalmic findings: SST report no. 13.

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.

Surgery for subfoveal choroidal neovascularization in age-related macular degeneration: quality-of-life findings: SST report no. 12.

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.

Surgery for subfoveal choroidal neovascularization in age-related macular degeneration: ophthalmic findings: SST report no. 11.

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.

Health- and vision-related quality of life among patients with choroidal neovascularization secondary to age-related macular degeneration at enrollment in randomized trials of submacular surgery: SST report no. 4.

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).

Clinical trial performance of community- vs university-based practices in the submacular surgery trials (SST): SST report no. 2.

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.

Measurement and analysis of visual acuity in multicenter randomized clinical trials in the United States: findings from a survey.

Purpose: 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).

Methods: 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.

The prognostic significance of a system for classifying mechanical injuries of the eye (globe) in open-globe injuries.

Purpose: 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.

Methods: 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.

Responsiveness of the National Eye Institute Visual Function Questionnaire to changes in visual acuity: findings in patients with subfoveal choroidal neovascularization--SST Report No. 1.

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.

Intraoperative ketorolac and eye pain after viteoretinal surgery: a prospective, randomized, placebo-controlled study.

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.

Consistency between visual acuity scores obtained at different test distances: theory vs observations in multiple studies.

Objective: To investigate the consistency of visual acuity (VA) scores measured at 2 different distances in patients with or at risk for choroidal neovascularization.

Methods: Best-corrected VA scores measured at 2 distances for the same eyes at the same examinations were collected from 4 sets of randomized clinical trials among patients with or at risk of choroidal neovascularization. Within each trial, the pairs of VA scores were compared and their relationship was explored.

Consistency of observations from echograms made centrally in the Collaborative Ocular Melanoma Study COMS Report No. 13.

Purpose: 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.

Methods: 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.