Biomedical subjects
Publications and source records attributed to Neil M Bressler.
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OBJECTIVE: To evaluate the safety and effect on visual acuity of photodynamic therapy with verteporfin (Visudyne, Novartis AG) in patients with subfoveal choroidal neovascularization (CNV) secondary to the ocular histoplasmosis syndrome (OHS). DESIGN: Open-label, three-center, noncomparative prospective case series. PARTICIPANTS: OHS patients with subfoveal CNV lesions no larger than 5400 micro m in greatest linear dimension (GLD) with classic or occult CNV extending under the geometric center of the foveal avascular zone and best-corrected visual acuity letter score of 73 to 34 (approximate Snellen equivalent 20/40-20/200). METHODS: Twenty-six patients received verteporfin (6 mg/m(2)) infused IV over 10 minutes. Fifteen minutes after the start of infusion, a laser light at 689 nm delivered 50 J/cm(2) at an intensity of 600 mW/cm(2) over 83 seconds using a spot size with a diameter 1000 micro m larger than the GLD of the lesion. At 3-month follow-up examinations, retreatment with the same regimen was applied if angiography showed fluorescein leakage. Safety assessments were also made. MAIN OUTCOME MEASURES: Visual function measurements were the changes from baseline in visual acuity and contrast sensitivity scores and the proportion of patients who, based on best-corrected visual acuity scores, (1) gained 7 or more letters, (2) lost 8 or more letters, and (3) lost 15 or more letters. RESULTS: One patient was omitted from the study at the month 3 examination for not meeting the visual acuity eligibility requirements at baseline. By the month 12 examination, but excluding any retreatment at that visit, patients had received an average of 2.9 treatments of a maximum of 4 possible treatments. The month 12 median improvement from baseline in visual acuity of the remaining 25 patients was 7 letters, and median contrast sensitivity improved by 2 letters. Median visual acuity improvement was also 7 letters when three patients, who failed to meet all photographic eligibility requirements at baseline, were excluded. At the month 12 examination, 14 (56%) patients gained 7 or more letters of visual acuity from baseline, whereas 4 (16%) patients lost 8 or more letters, of which 2 (8%) lost 15 or more letters. No serious systemic or ocular adverse events were reported. CONCLUSIONS: Median visual acuity improved after verteporfin therapy for at least 1 year in a small uncontrolled prospective case series of patients with subfoveal CNV caused by OHS. Verteporfin therapy seemed to be safe and well tolerated in these patients. Two-year data from this study will provide important, additional information on the safety and effect of verteporfin therapy for the treatment of subfoveal CNV secondary to OHS.
BACKGROUND: In the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy (TAP) investigation, verteporfin therapy reduced the risk of at least moderate vision loss (defined as a loss of at least 15 letters of visual acuity) in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (ARMD). This report presents detailed analyses of 24-month contrast sensitivity outcomes in these patients. METHODS: The patients included in the TAP investigation had subfoveal CNV secondary to ARMD and received verteporfin therapy (n = 402) or placebo (n = 207) at the first visit, with retreatment at each 3-month follow-up visit if angiography revealed fluorescein leakage from CNV. Contrast sensitivity was determined at each visit using a Pelli-Robson chart. RESULTS: At the month 24 examination, verteporfin-treated patients were less likely to lose at least 6 or 15 letters of contrast sensitivity than placebo-treated patients (86 [21%] versus 94 [45%], and 27 [7%] versus 24 [12%], respectively; P < 0.05 for both comparisons). The superiority of verteporfin therapy over placebo was greater in patients with predominantly classic CNV at baseline, although verteporfin-treated patients with minimally classic CNV also had better contrast sensitivity outcomes. CONCLUSIONS: Consistent with visual acuity outcomes, verteporfin therapy reduced the risk of a clinically relevant loss of contrast sensitivity in the total study population, with the greatest effect in patients with predominantly classic subfoveal CNV secondary to ARMD. Verteporfin-treated patients with minimally classic CNV also had better contrast sensitivity outcomes than patients who received placebo. Given the association between contrast sensitivity and visual disability, the beneficial effects of verteporfin therapy on contrast sensitivity outcomes are expected to have a favorable impact on patients' daily activities.
PURPOSE: To report three cases of choroidal neovascularization (CNV) that occurred following surgical disruption of Bruch membrane during macular surgery. METHODS: A retrospective case series was compiled. Macular translocation surgery with punctate retinotomy was performed in two patients for subfoveal CNV, and pars plana vitrectomy with epiretinal membrane (ERM) peeling was performed in one patient for idiopathic ERM. RESULTS: CNV developed at a site of subretinal cannulation in two cases of macular translocation, and at a site of inadvertent injury to Bruch membrane with a vitreoretinal pick in the one case that underwent ERM peeling. CONCLUSIONS: These cases underscore the need to monitor breaks in Bruch membrane for CNV following macular surgery.
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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.
PURPOSE: To compare the preferential hyperacuity perimeter (PHP) with an Amsler grid in detection of age-related macular degeneration (AMD). METHODS: Patients underwent refraction, visual acuity examination, PHP, Amsler grid examination, and macular photography. RESULTS: One hundred fifty patients participated in the trial. Of 19 eyes with neovascular AMD, 19 (100%) were positive on the PHP, and 10 (53%), on the Amsler grid. Of 27 eyes with geographic atrophy, 26 (96%) were positive on the PHP, and 12 (44%), on the Amsler grid. Of 20 eyes with intermediate AMD, 14 (70%) were positive on the PHP, and 4 (20%), on the Amsler grid. Of 51 eyes with early AMD, 21 (41%) were positive on the PHP, and 4 (8%), on the Amsler grid. Of 33 eyes with no AMD, 6 (18%) were positive on the PHP, and none, on the Amsler grid. Thus, 80 (68%) of 117 patients with AMD had a positive PHP, while 30 (26%) had positive results of Amsler grid examination (P < 0.001, McNemar test). CONCLUSION: The PHP had greater sensitivity, although with a relatively high rate of false-positive results for healthy individuals, than the Amsler grid in detecting AMD-related lesions.
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BACKGROUND: The neovascular form of age-related macular degeneration (AMD) can rapidly lead to severe loss of central vision and adversely affect the patient's quality of life. During the 1990s the only proven treatment for neovascular AMD was laser photocoagulation. Only a minority of patients are eligible to receive this treatment, however, and the treatment itself can cause acute retinal damage with immediate vision loss. Verteporfin therapy is a new treatment option involving photodynamic therapy that was recently shown to be relatively safe and effective in reducing the risk of vision loss in selected cases. METHODS: Recent literature was reviewed on management of choroidal neovascularization caused by AMD that proved beneficial in large-scale randomized clinical trials. These studies were selected through a MEDLINE search of files from 1982 to the present using the keywords "randomized clinical trials," "choroidal neovascularization," and "age-related macular degeneration," as well as through personal knowledge of recently completed trials. RESULTS AND CONCLUSIONS: Primary care physicians can effect good treatment outcomes by detecting early signs of AMD and educating patients about the necessity of prompt referral to an ophthalmologist. Immediate referral is increasingly important because, compared with laser photocoagulation, current photodynamic therapy with verteporfin is applicable to more patients. Greater patient awareness of neovascular AMD and the importance of self-testing of vision can also be communicated to patients in primary care.
OBJECTIVE: To evaluate the ability of a retina specialist's grading of 30 degrees color stereoscopic fundus photographs to identify areas of significant retinal thickening as assessed by the Retinal Thickness Analyzer (RTA) and to determine whether this ability was affected by the presence of retinal pathology. MATERIALS AND METHODS: Thirty-two eyes in 29 patients clinically diagnosed as having diabetic macular edema underwent RTA scanning and nonsimultaneous 30 degrees color stereoscopic fundus photography. Retinal thickness maps of the macular area were generated, and regions with significant retinal thickening (> or = 2 SD above normal values) were identified. A retina specialist reader, masked to the RTA measurements, identified areas with macular edema on the stereoscopic fundus photographs, which subsequently were overlaid on the retinal thickness maps. The sensitivity (percent of significant retinal thickening areas identified by the retina specialist grading the stereoscopic fundus photographs) was calculated separately for areas with and without retinal pathology. Specificity of the stereoscopic fundus photograph grading was assessed similarly. RESULTS: The retina specialist's stereoscopic fundus photography grading identified 78.8% of areas with significant retinal thickening (range over eyes: 20.4%-100%) and was slightly more likely to identify significant retinal thickening when pathology was present (89.6%) than when pathology was not present (78.4%; pooled risk ratio, 1.14 [95% CI = 0.54, 2.42]). Specificity of stereoscopic fundus photography grading was 58%, ie, 42% of areas without significant retinal thickening were (incorrectly) identified as edematous by the stereoscopic fundus photograph grading. This misidentification was more likely if pathology was present (76.9%) than if pathology was not present (41.1%; pooled risk ratio, 1.87 [95% CI = 1.28, 2.73]). CONCLUSION: This study shows the determination of macular edema by a retina specialist reading color stereoscopic fundus photographs is sensitive but not specific with reference to edema identified by the RTA. Furthermore, the presence of retinopathy tends to cause false-positive readings with reference to edema identified by the RTA. These findings indicate the need to use objective, quantitative methods in clinical studies to detect and monitor macular edema.