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Neil M Bressler

Publications and source records attributed to Neil M Bressler.

At least 37 records · Page 2Linked to original sources
PubMed2004

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. 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.

Adult↗
PubMed2004

Patients' perceptions of the value of current vision: assessment of preference values among patients with subfoveal choroidal neovascularization--The Submacular Surgery Trials Vision Preference Value Scale: SST Report No. 6.

OBJECTIVE: To improve understanding and awareness of the impact of subfoveal choroidal neovascularization (CNV) on health-related quality of life, we sought to measure the preference value that patients with subfoveal CNV assigned to their health and vision status. PATIENTS AND METHODS: Patients with subfoveal CNV completed telephone interviews about their quality of life prior to enrollment and random treatment assignment in the Submacular Surgery Trials, a set of multicenter randomized controlled trials evaluating outcomes of submacular surgery compared with observation. The interviewers asked patients to rate their current vision on a scale from 0 (completely blind) to 100 (perfect vision). The interviewers also asked them to rate complete blindness and then perfect vision, assuming their health otherwise was the same as it was at the time of the interview, on a scale from 0 (dead) to 100 (perfect health with perfect vision). Scores were converted to a 0 to 1 preference value scale for health and vision status, where 0 represents death and 1 represents perfect health and vision. RESULTS: Of 1015 participants enrolled in the Submacular Surgery Trials, 996 completed interviews that included the rating questions, and 792 (80%) answered all 3 rating questions in a manner permitting calculation of a single overall preference value for their current health and vision status on a scale from 0 (dead) to 1 (perfect). The mean preference value was 0.64 (median, 0.68; interquartile range, 0.51-0.80). The preference values correlated with age (Pearson correlation coefficient, -0.11; P = .002), patients' self-rated perception of overall health (Spearman correlation coefficient, 0.36; P<.001), and self-reported perception of vision (Spearman correlation coefficient, 0.47; P<.001). The preference values were significantly lower with poorer visual acuity in the better eye and greater evidence of dysfunction on either the Hospital Anxiety and Depression Scale or the Physical or Mental Component Summary scales of the Short Form-36 Health Survey but did not differ significantly by gender or other baseline characteristics such as race, treatment assignment, or size of the CNV lesion. CONCLUSIONS: Vision loss from subfoveal CNV is associated with patient preference values that are as low as or lower than values previously reported for other serious medical conditions such as dialysis-dependent renal failure and AIDS, indicating that both unilateral and bilateral CNV have a profound impact on how patients feel about their overall health-related quality of life.

Adult↗
PubMed2004

Natural history of minimally classic subfoveal choroidal neovascular lesions in the treatment of age-related macular degeneration with photodynamic therapy (TAP) investigation: outcomes potentially relevant to management--TAP report No. 6.

OBJECTIVE: To determine if there is a rationale for monitoring patients with age-related macular degeneration who have a minimally classic subfoveal choroidal neovascular lesion and do not receive treatment at initial examination. METHODS: Participants assigned to placebo who had a minimally classic lesion composition at baseline were identified from the TAP Investigation. Fluorescein angiograms at baseline and follow-up examinations from these participants were reviewed by photograph reading center graders to determine if any follow-up angiograms had converted from a minimally classic lesion composition to a predominantly classic lesion composition. MAIN OUTCOME MEASURES: Proportion of minimally classic lesions at baseline that converted to a predominantly classic lesion composition, time of this conversion, and visual acuity and lesion size at the time of conversion. RESULTS: Of the 207 patients assigned to placebo in the TAP Investigation, 98 were judged to have a minimally classic lesion at baseline in the study eye when the fluorescein angiograms were reviewed in 2001. Of these 98 patients, 39 (40%) had lesions that converted to a predominantly classic lesion composition, including 21 by the month 3 examination. At the time of conversion, 32 (82%) lesions were no greater than 9 disc areas, including 20 (51%) with visual acuity of 20/200 or better. CONCLUSIONS: These data would suggest that patients with minimally classic lesions, in whom no therapy is recommended initially, should be monitored so that potential conversion to a predominantly classic lesion can be identified promptly and verteporfin therapy considered.

Choroidal Neovascularization↗
PubMed2004

Detection of diabetic foveal edema: contact lens biomicroscopy compared with optical coherence tomography.

OBJECTIVE: To compare contact lens biomicroscopy with optical coherence tomography (OCT) for the detection of diabetic foveal edema. METHODS: Study participants consisted of a convenient cohort of consecutive patients with diabetes mellitus seen at the Wilmer Eye Institute's Retinal Vascular Center, Baltimore, MD. Case characteristics were recorded and eyes were examined by 1 of 4 retina specialists by means of contact lens biomicroscopy. Edema involving the center of the macula was assessed as definitely present, questionably present, or definitely not present. The OCT testing was performed and interpreted by trained technicians, masked to the physicians' assessment of foveal edema. Agreement between OCT and contact lens examination for the absence or presence of foveal edema was evaluated. RESULTS: One hundred seventy-two eyes of 95 patients with diabetes were enrolled in August and September 2002. Foveal thickness was objectively measured by OCT in 170 (99%) of 172 cases. We found excellent agreement between OCT and contact lens examination for the absence or presence of foveal edema when OCT thickness was normal ( 300 microm). However, agreement was poor when foveal thickness was mildly increased on OCT (201-300 microm). CONCLUSIONS: Agreement between contact lens examination and OCT for the detection of diabetic foveal edema is poor when OCT thickening is mild. This suggests that contact lens biomicroscopy is relatively insensitive for the detection of mild foveal thickening apparent on OCT. Additional studies are needed to investigate the natural course of cases with mildly increased foveal thickness on OCT that do not appear thickened clinically.

Adult↗
PubMed2004

Relative contributions of reduced vision and general health to NEI-VFQ scores in patients with neovascular age-related macular degeneration.

OBJECTIVE: To estimate the relative contributions of central vision loss and general health to vision-targeted quality of life as measured by the National Eye Institute Visual Function Questionnaire (NEI-VFQ). METHODS: Data on quality of life (NEI-VFQ and the 36-Item Short-Form Health Survey [SF-36]) and visual acuity were collected as part of the Submacular Surgery Trials Pilot Study. Information on medical conditions was collected by patient chart review. Twenty-four-month data for 120 patients were analyzed using linear regression methods. RESULTS: Median patient age at the 24-month examination was 77 years; 60% were women, and 98% were non-Hispanic whites. A 3-line decrement in visual acuity in the better-seeing eye was associated with a 5.1- to 17.1-point decrement in NEI-VFQ scores after adjustment for general health (SF-36 physical component summary [PCS] and mental component summary [MCS] scores). A 10-point decrement in the PCS score was associated with a 4- to 9-point decrement in NEI-VFQ scores after adjustment for visual acuity in the better-seeing eye and MCS score. A 10-point decrement in the MCS score was associated with a 4- to 8-point decrement in NEI-VFQ scores after adjustment for visual acuity in the better-seeing eye and PCS score. Diabetes, arthritis/rheumatism, and hypertension also had large effects on NEI-VFQ scores in the adjusted analysis. CONCLUSIONS: The NEI-VFQ is sensitive to differences in visual acuity in the better-seeing eye, as expected, and to differences in general health. Adjustment for general health should be considered when comparing NEI-VFQ scores between patient groups.

Aged↗
PubMed2004

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. 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.

Choroidal Neovascularization↗
PubMed2004

Large submacular hemorrhages after verteporfin therapy.

PURPOSE: To report the occurrence of large submacular hemorrhages after photodynamic therapy with verteporfin in age-related macular degeneration patients with subfoveal choroidal neovascularization (CNV) composed of occult with no classic CNV in whom the hemorrhage precluded determining if additional therapy should be given within 3 months after initiation of treatment. DESIGN: Retrospective, noncomparative case series. METHODS: The records of all age-related macular degeneration patients who received verteporfin therapy for subfoveal lesions composed of occult with no classic CNV between February and July 2001 at The Wilmer Eye Institute were reviewed. Subjects who reported either having undergone a procedure to remove intraocular blood before a month 3 follow-up visit, or who had submacular hemorrhage at the month 3 visit that was severe enough to preclude determining if additional verteporfin therapy should be given were identified. RESULTS: Fifty-five eyes of 52 patients were reviewed. Five eyes (9% [95% confidence interval, 1.4%-16.6%]) developed submacular hemorrhage that precluded determining if additional verteporfin therapy should be given. Visual acuity 3 months after documentation of the hemorrhage decreased a median of 8.5 lines compared with pretreatment acuity. CONCLUSIONS: Even in the absence of acute severe visual acuity decrease, submacular hemorrhage after verteporfin therapy can be associated with severe vision loss and preclude determining if additional therapy should be given.

Aged↗
PubMed2004

Comparability of two fundus photograph reading centers in grading cytomegalovirus retinitis progression.

PURPOSE: To compare grading of cytomegalovirus retinitis progression by two different fundus photograph reading centers (FPRCs). DESIGN: Patients with AIDS followed in an ophthalmology service were enrolled in a prospective epidemiologic study of the prevalence and incidence of resistant cytomegalovirus in vitro. METHODS: We compared masked replicate gradings by two different FPRCs of monthly fundus photographs for retinitis progression (onset of a separate new lesion or expansion of an existing lesion by > or =one-half disk diameter). RESULTS: For 77 patients, Kaplan-Meier plots of progression over time were similar between FPRCs (median time to progression, 65 vs 69 days). Agreement between FPRCs was 51% (kappa [kappa] =.37, "fair") on exact visit of progression (28 patients) or on absence of progression through follow-up (11 patients) and 62% (kappa =.38) on progression visit +/- 1 month. Eight of 12 patients with progression graded as more than 1 month apart were only 2 months apart. Considering each monthly visit as a choice point, overall agreement on progression was 78% (kappa =.55, "moderate"). Baseline evaluation of retinitis showed 95% agreement on presence/absence and a concordance correlation coefficient of.75 for extent in combined zones 1 and 2. Rates of retinal loss over follow-up were estimated as 2.8%/month vs 2.0%/month (P =.015). CONCLUSIONS: By adopting similar protocols and procedures, different FPRCs can achieve good agreement on presence and extent of cytomegalovirus retinitis. Further efforts to harmonize evaluation through ongoing comparison of gradings would likely improve agreement on retinitis progression.

AIDS-Related Opportunistic Infections↗
PubMed2004

Is adjustment of National Eye Institute Visual Function Questionnaire scores for general health necessary in randomized trials?

PURPOSE: To assess whether treatment comparison of National Eye Institute Visual Function Questionnaire (NEI-VFQ) scores in a clinical trial is influenced by general health to warrant adjusting for it. DESIGN: Two randomized pilot trials. METHODS: Patients enrolled in two randomized pilot trials of submacular surgery versus observation for choroidal neovascularization had quality of life interviews (NEI-VFQ and the Short Form-36 Health Survey) 24 months after enrollment. Information on comorbidities was collected through chart reviews. Data from 120 patients were analyzed using linear regression methods. RESULTS: Adjustment for comorbidities did not change the magnitude of the treatment effect on NEI-VFQ scores. However, adjustment for Short Form-36 physical and mental component summaries produced changes in the estimated treatment effect when NEI-VFQ scores were compared. CONCLUSIONS: Adjustment of NEI-VFQ scores for general health may be advisable. The Short Form-36 summary scores may be appropriate for this purpose.

Aged↗
PubMed2004

Acute severe visual acuity decrease after photodynamic therapy with verteporfin: case reports from randomized clinical trials-TAP and VIP report no. 3.

PURPOSE: To describe in detail occurrences of acute severe visual acuity decrease after photodynamic therapy (PDT) with verteporfin in the Treatment of Age-related macular degeneration with Photodynamic therapy (TAP) Investigation and the Verteporfin In Photodynamic therapy (VIP) Trial. DESIGN: Observational case series. METHODS: Retrospective review of all cases that developed acute severe visual acuity decrease after treatment. RESULTS: Of 15 acute severe visual acuity decrease events originally identified in 14 eyes of 14 patients, one event in one patient was judged unlikely to have been an acute severe visual acuity decrease event on retrospective review of these events in preparation of this report. Eleven events occurred after the first treatment. At follow-up, 10 improved by at least 1 line in visual acuity from the level noted at the time of the event. Of the nine patients returning for the month 24 examination, visual acuity decreased at least 3 lines from baseline in six, including at least 6 lines in four, and remained within 1 line in three. Associated abnormal morphology included three with a serous macular detachment and abnormal choroidal hypofluorescence, four with macular hemorrhage, three with a greenish subfoveal hemorrhage, and four with no abnormality. Events appeared to be more likely when patients had a visual acuity of 20/50 or better. CONCLUSIONS: Acute severe visual acuity decrease after PDT with verteporfin was an uncommon event; the risk did not outweigh the benefits of therapy previously reported. When considering verteporfin therapy, patients should be warned of the possibility of this serious adverse event.

Acute Disease↗
PubMed2004

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). 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.

Aged↗
PubMed2004

Radiation retinopathy after fractionated stereotactic radiotherapy for optic nerve sheath meningioma.

PURPOSE: To report a patient with radiation retinopathy after fractionated stereotactic radiotherapy for treatment of optic nerve sheath meningioma (ONSM). DESIGN: Interventional case report. METHODS: The clinical presentation, radiation treatment, and subsequent visual complications of a patient with ONSM are described. MAIN OUTCOME MEASURES: Development of radiation retinopathy and Snellen visual acuity. RESULTS: A 36-year-old man presented with a left optic neuropathy. Magnetic resonance imaging studies showed abnormalities consistent with ONSM. Because of progressive vision loss, the patient underwent fractionated stereotactic radiotherapy for the lesion. Vision initially improved after treatment, but 22 months later, retinal abnormalities consistent with radiation retinopathy were noted in the left eye. Visual acuity worsened over the next 24 months in association with the development of retinal hemorrhages, lipid, and retinal edema predominantly within the nasal portion of the posterior pole. Fluorescein angiography showed edema associated with microaneurysms, retinal telangiectasia, and capillary nonperfusion. Laser photocoagulation was performed on several occasions in areas of microaneurysms and retinal telangiectasia; however, the retinal edema and lipid remained, associated with persistent decreased vision. CONCLUSIONS: Radiation retinopathy and vision loss may occur after fractionated stereotactic radiotherapy for ONSM and should be discussed as a potential complication.

Adult↗
PubMed2004

Photodynamic therapy with verteporfin in ocular histoplasmosis: uncontrolled, open-label 2-year study.

OBJECTIVE: To evaluate the safety, effect on visual function, and fluorescein angiographic appearance of subfoveal choroidal neovascularization (CNV) through 2 years after photodynamic therapy with verteporfin (Visudyne; Novartis AG, Basel, Switzerland) in patients with ocular histoplasmosis syndrome (OHS). DESIGN: Open-label, 3-center, uncontrolled clinical study. PARTICIPANTS: Ocular histoplasmosis syndrome patients with subfoveal CNV (N = 26) with a greatest linear dimension no larger than 5400 microm with classic or occult CNV extending under the geometric center of the fovea, and best-corrected visual acuity letter score of approximately 20/40 to 20/200. METHODS: The methods were similar to those described in the 1-year results with follow-up examinations every 3 months continuing through the second year. During the second year, additional therapy was recommended if fluorescein angiography showed leakage at a scheduled visit. MAIN OUTCOME MEASUREMENTS: Visual function measurements included the changes from baseline in visual acuity and contrast sensitivity scores. Lesion size and leakage from classic and occult CNV were assessed at month 12 and month 24. Safety assessments also were made. RESULTS: A 24-month examination was completed in 22 of the 26 enrolled participants (85%). At the 24-month examination, median improvement from baseline in visual acuity of the 22 patients evaluated was 6 letters; median contrast sensitivity improved by 3.5 letters. At the 24-month examination, 10 patients (45%) gained 7 or more letters of visual acuity from baseline, whereas 4 patients (18%) lost 8 or more letters, including 2 patients (9%) who lost at least 15 letters. There was absence of fluorescein angiographic leakage from classic CNV in 17 of the 20 evaluable lesions (85%), and leakage from occult CNV was absent in all eyes. No serious ocular adverse events were reported, and no serious systemic event was considered to be associated with treatment. CONCLUSIONS: Median visual acuity improved and fluorescein angiographic leakage decreased after verteporfin therapy in this small, uncontrolled clinical study of patients with subfoveal CNV resulting from OHS. Verteporfin therapy seemed to be relatively safe in these patients. The selected cases feature fluorescein angiographic examples of CNV that are important in determining when to apply verteporfin therapy.

Adult↗
PubMed2004

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. Any contiguous blood had to account for <50% of the total area occupied by the subfoveal lesion (maximum size, 9.0 disc areas [22.9 mm2]). METHODS: Randomization was stratified by VA and by clinical center. All patients were scheduled for study examinations at 3, 6, 12, and 24 months after enrollment for assessment of study outcomes. MAIN OUTCOME MEASURE: A successful outcome was defined a priori to be either improvement of BCVA or VA no more than 1 line (7 letters) worse than baseline at the 24-month examination. RESULTS: Of 454 patients enrolled, 228 study eyes were assigned to observation and 226 to surgery. The percentages of eyes that had successful outcomes were similar in the 2 arms: 44% assigned to observation and 41% assigned to surgery. Median VA losses from baseline to the 24-month examination were 2.1 lines (10.5 letters) in the observation arm and 2.0 lines (10 letters) in the surgery arm. Median VA declined from 20/100 at baseline to 20/400 at 24 months in both arms. No subgroup of patients was identified in which submacular surgery led to better VA outcomes. In the surgery arm, 55 (39%) of 142 initially phakic eyes had cataract surgery by the 24-month examination, compared with 6 (5%) of 133 eyes in the observation arm. Rhegmatogenous retinal detachment occurred in 12 surgery eyes (5%) and 1 observation eye. CONCLUSIONS: Submacular surgery, as performed in this clinical trial, did not improve or preserve VA for 24 months in more eyes than observation and is not recommended for patients with similar lesions. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.

Aged↗
PubMed2004

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 =9.0 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.

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PubMed2004

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 3.5 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.

Aged↗