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Biomedical subjects

F L Ferris

Publications and source records attributed to F L Ferris.

At least 37 records · Page 2Linked to original sources
PubMed1995

Effects of aspirin on vitreous/preretinal hemorrhage in patients with diabetes mellitus. Early Treatment Diabetic Retinopathy Study report no. 20.

OBJECTIVE: To assess whether the use of aspirin exacerbates the severity or duration of vitreous/preretinal hemorrhages in patients with diabetic retinopathy. DESIGN: The Early Treatment Diabetic Retinopathy Study (ETDRS), a multicenter randomized clinical trial, was designed to assess the effect of photocoagulation and aspirin on 3711 patients with mild to severe nonproliferative or early proliferative diabetic retinopathy. INTERVENTION: Patients were randomly assigned to either an aspirin (650 mg/d) or a placebo group. One eye of each patient was randomly assigned to early photocoagulation and the other to deferral of photocoagulation. MAIN OUTCOME MEASURES: The severity and duration of the vitreous/preretinal hemorrhages were determined from gradings of the annual, seven standard stereoscopic field, fundus photographs. Clinical examinations scheduled every 4 months also provided information on the presence and duration of hemorrhages. RESULTS: Annual fundus photographs of eyes assigned to deferral of photocoagulation revealed vitreous/preretinal hemorrhages at some time during follow-up in 564 patients (30%) assigned to the placebo group and 585 patients (32%) assigned to the aspirin group (P = .48). Based on gradings of fundus photographs, there were no statistical differences in the severity of vitreous/preretinal hemorrhages (P = .11) or their rate of resolution (P = .86) between the groups. Clinical examination of eyes assigned to deferral of photocoagulation revealed 721 eyes (39%) assigned to the aspirin group and 689 (37%) assigned to the placebo group that had vitreous/preretinal hemorrhages during the course of the study (P = .30). Again, no statistically significant difference was found between the rates of resolution, as assessed clinically, between the two treatment groups (P = .43). CONCLUSIONS: As previously reported, the use of aspirin did not increase the occurrence of vitreous/preretinal hemorrhages in patients enrolled in the ETDRS. The data presented in this report demonstrate that the severity and duration of these hemorrhages were not significantly affected by the use of aspirin and that there were no ocular contraindications to its use (650 mg/d) in persons with diabetes who require it for treatment of cardiovascular disease or for other medical indications.

Adult↗
PubMed1995

Accommodative amplitudes in the Early Treatment Diabetic Retinopathy Study.

PURPOSE: Accommodative amplitude in persons with diabetes was investigated using data collected as part of the Early Treatment Diabetic Retinopathy Study. METHODS: Accommodative amplitude was measured at the baseline visit in 1,058 patients who had good visual acuity and who were less than 46 years old. Risk factors for low accommodative amplitude at baseline were evaluated using multivariable linear regression. Change in accommodative amplitude after photocoagulation was evaluated using paired t tests and repeated measures analysis of variance for the 578 patients who underwent follow-up measurements at the 4-month visit. RESULTS: Accommodative amplitudes in Early Treatment Diabetic Retinopathy Study patients were lower than normal accommodative amplitudes. Older age (P < 0.001) and increased duration of diabetes (P < 0.01) were risk factors associated with low amplitudes of accommodation in the Early Treatment Diabetic Retinopathy Study. Full scatter photocoagulation was associated with an apparently transient additional reduction in accommodative amplitude; a one third diopter loss in accommodative amplitude was demonstrated only at the 4-month visit (P < 0.001). CONCLUSION: This study demonstrates that diabetes and duration of diabetes, along with age, are important risk factors for reduced accommodative amplitude. These factors along with an apparently transient decrease in accommodative amplitude following scatter photocoagulation should be considered when assessing the accommodative needs of patients with diabetes and when discussing side effects of full scatter photocoagulation.

Accommodation, Ocular↗
PubMed1995

Digoxin does not accelerate progression of diabetic retinopathy.

OBJECTIVE: To test the hypothesis that digoxin, an inhibitor of Na(+)-K(+)-ATPase activity, accelerates the progression of diabetic retinopathy. RESEARCH DESIGN AND METHODS: We compared the incidence and risk of retinopathy in 120 digoxin-taking vs. 867 non-digoxin-taking diabetic participants in the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) and in 117 digoxin-taking vs. 1,883 non-digoxin-taking diabetic subjects in the Early Treatment Diabetic Retinopathy Study (ETDRS). In both studies, retinopathy was detected by grading stereoscopic color photographs using the modified Airlie House classification scheme, and a two-step difference in baseline retinopathy grade was considered significant. RESULTS: After controlling for other risk factors, we found no statistically significant association with either 4-year incidence of retinopathy (WESDR) or progression of retinopathy (WESDR and ETDRS) in patients taking digoxin at baseline compared with those not taking digoxin. CONCLUSIONS: These data suggest that digoxin therapy does not adversely affect the course of diabetic retinopathy.

Adult↗
PubMed1994

Treatment of cytomegalovirus retinitis with an intraocular sustained-release ganciclovir implant. A randomized controlled clinical trial.

BACKGROUND AND METHODS: We performed a randomized controlled clinical trial to assess the safety and efficacy of a 1 microgram/h ganciclovir implant for the treatment of newly diagnosed cytomegalovirus (CMV) retinitis in patients with the acquired immunodeficiency syndrome (AIDS). Patients with previously untreated peripheral CMV retinitis were randomly assigned either to immediate treatment with the ganciclovir implant or to deferred treatment. Standardized fundus photographs were taken at 2-week intervals and analyzed in a masked fashion. The study end point was progression of retinitis based on the photographic assessment. RESULTS: Twenty-six patients (30 eyes) were enrolled. The median time to progression of retinitis was 15 days in the deferred treatment group (n = 16) vs 226 days in the immediate treatment group (n = 14) (P < .00001, log-rank test). During the study, 39 primary implants and 12 exchange implants were placed in immediate-treatment eyes, deferred-treatment eyes that progressed, or contralateral eyes that developed CMV retinitis. Postoperative complications in the total series included seven late retinal detachments and one retinal tear without detachment. Final visual acuity was 20/25 or better in 34 of 39 eyes. The estimated risk of developing CMV retinitis in the fellow eye was 50% at 6 months. Biopsy-proven visceral CMV disease developed in eight (31%) of 26 patients. The median survival was 295 days. CONCLUSION: The ganciclovir implant is effective for the treatment of CMV retinitis. Patients with unilateral CMV retinitis treated with the implant are likely to develop CMV retinitis in the fellow eye, and some patients will develop visceral CMV disease.

AIDS-Related Opportunistic Infections↗
PubMed1994

Results of 20 years of research on the treatment of diabetic retinopathy.

Diabetic retinopathy is the leading cause of blindness in young adults, ages 20-55. Without treatment 50% of those with proliferative diabetic retinopathy will be blind within 5 years. Over the last 2 decades the National Eye Institute has supported four different multicenter randomized clinical trials for diabetic retinopathy. Implementation of the results from these clinical trials can markedly reduce the risk of blindness.

Aldehyde Reductase↗
PubMed1994

Preventive eye care in people with diabetes is cost-saving to the federal government. Implications for health-care reform.

OBJECTIVE: Diabetic retinopathy, which leads to macular edema and retinal neovascularization, is the leading cause of blindness among working-age Americans. Previous research has demonstrated significant cost savings associated with detection of eye disease in Americans with type I diabetes. However, detection and treatment of eye disease among those with type II diabetes was previously thought not to be cost-saving. Our purpose was to estimate the current and potential federal savings resulting from the screening and treatment of retinopathy in patients with type II diabetes, based on recently available data concerning efficacy of treating both macular edema and neovascularization along with new data on federal budgetary costs of blindness. RESEARCH DESIGN AND METHODS: We used computer modeling, incorporating data from population-based epidemiological studies and multicenter clinical trials. Monte Carlo simulation was used, combined with sensitivity analysis and present value analysis of cost savings. RESULTS: Screening and treatment for eye disease in patients with type II diabetes generates annual savings of $247.9 million to the federal budget and 53,986 person-years of sight, even at current suboptimal (60%) levels of care. If all patients with type II diabetes receive recommended care, the predicted net savings (discounted at 5%) exceeds $472.1 million and 94,304 person-years of sight. Nearly all savings are associated with detection and treatment of diabetic macular edema. Enrolling each additional person with type II diabetes into currently recommended ophthalmological care results in an average net savings of $975/person, even if all costs of care are borne by the federal government. CONCLUSIONS: Our analysis indicates that prevention programs aimed at improving eye care for patients with diabetes not only reduce needless vision loss but also will provide a financial return on the investment of public funds.

Blindness↗
PubMed1993

Relative letter and position difficulty on visual acuity charts from the Early Treatment Diabetic Retinopathy Study.

Ten Sloan letters were used in the visual acuity charts developed for use in the Early Treatment Diabetic Retinopathy Study. We used the data from the 3,710 Early Treatment Diabetic Retinopathy Study subjects to investigate the relative difficulty of the ten Sloan letters and to evaluate whether the position of a letter on a line affected its relative difficulty. In general, our findings were consistent with those of the previous study. The four letters with curved contours (C, O, S, and D) were more difficult to discern at threshold than the six letters (Z, N, H, V, R, and K) composed of straight lines. Our data demonstrate that under these test conditions, letters at the end of a line are more likely to be read incorrectly than letters at the beginning of the line. This finding indicates that these data are probably not useful for evaluating possible crowding phenomena.

Diabetic Retinopathy↗
PubMed1993

Issues in management of diabetic retinopathy.

Panretinal photocoagulation could prevent most blindness from proliferative disease--if risk is identified early. This makes it essential that primary physicians include annual ophthalmologic evaluation in the management of patients at risk. Meanwhile, studies are under way on promising medical approaches, including intensive insulin regimens, aldose reductase blockers, and angiogenesis inhibitors.

Animals↗
PubMed1993

Diabetic retinopathy.

OBJECTIVE: To review the natural history and treatment indications for diabetic retinopathy. RESEARCH DESIGN AND METHODS: Studies of the natural history of diabetic retinopathy and major clinical trials sponsored by the National Eye Institute were reviewed. RESULTS: Diabetic retinopathy remains a leading cause of vision disability in the U.S. Vision loss results from the consequences of proliferative retinopathy or macular edema. Photocoagulation has been demonstrated to be an effective treatment for these complications of diabetes. CONCLUSIONS: All people with diabetes should be evaluated regularly to determine whether they would benefit from photocoagulation. As a referral guideline, any person with type I diabetes of > 5 yr duration and all people with type II diabetes or any retinopathy should be referred to an ophthalmologist.

Blindness↗
PubMed1992

Aspirin effects on the development of cataracts in patients with diabetes mellitus. Early treatment diabetic retinopathy study report 16.

The Early Treatment Diabetic Retinopathy Study, a randomized clinical trial supported by the National Eye Institute, was designed to assess the effect of photocoagulation and aspirin in 3711 patients with mild to severe nonproliferative or early proliferative diabetic retinopathy. Although the primary goal of the study was to evaluate the effect of photocoagulation and aspirin on diabetic retinopathy, the study also provided an opportunity to evaluate the effects of aspirin on the development of cataract. No evidence showed that aspirin use reduced the risk of development of cataract requiring extraction (4.1% vs 4.3% in patients assigned to aspirin or placebo treatment, respectively; Mantel-Cox P = .77; relative risk, 1.05; 99% confidence interval, 0.73 to 1.51). Aspirin use also did not reduce the risk of less extensive but visually significant lens opacities developing (29.6% vs 28.3%; Mantel-Cox P = .76; relative risk, 0.99; 99% confidence interval, 0.85 to 1.15). Early Treatment Diabetic Retinopathy Study results do not support the hypothesis that aspirin (at a dose of 650 mg/d) reduces the risk of cataract development in this diabetic population.

Adult↗
PubMed1992

Assessing the costs and benefits of medical research: the diabetic retinopathy study.

Significant amounts of scarce resources are devoted to medical research, but there have been few attempts to assess whether the benefits to society of these investments exceed the costs. A method for undertaking such an assessment has been developed and applied retrospectively to the Diabetic Retinopathy Study, a major clinical trial funded by the National Eye Institute from 1972-1981. It was estimated that the trial, which cost $10.5 million, generated a net saving of $2816 million to society ($231 million when the costs of lost production are excluded) (1982 prices) and a gain to patients of 279,000 vision years. This approach could be applied prospectively in considering priorities for medical research, in conjunction with traditional criteria such as the scientific merit of the proposal and the capabilities of the investigators. The key factors affecting the economic returns from medical research are the prevalence, incidence and economic burden of the disease in question, the costs and effectiveness of the medical intervention concerned, the likely impact of the clinical trial on clinical practice and the likely timespan of benefits from knowledge obtained during the trial.

Clinical Trials as Topic↗
PubMed1992

Pars plana vitrectomy in the Early Treatment Diabetic Retinopathy Study. ETDRS report number 17. The Early Treatment Diabetic Retinopathy Study Research Group.

BACKGROUND: The Early Treatment Diabetic Retinopathy Study (ETDRS) enrolled 3711 patients with mild-to-severe nonproliferative or early proliferative diabetic retinopathy in both eyes. Patients were randomly assigned to aspirin 650 mg/day or placebo. One eye of each patient was assigned randomly to early photocoagulation and the other to deferral of photocoagulation. Follow-up examinations were scheduled at least every 4 months, and photocoagulation was initiated in eyes assigned to deferral as soon as high-risk proliferative retinopathy was detected. Aspirin was not found to have an effect on retinopathy progression or rates of vitreous hemorrhage. The risk of a combined end point, severe visual loss or vitrectomy, was low in eyes assigned to deferral (6% at 5 years) and was reduced by early photocoagulation (4% at 5 years). Vitrectomy was carried out in 208 patients during the 9 years of the study. This report presents baseline and previtrectomy characteristics and visual outcome in these patients. METHODS: Information collected at baseline and during follow-up as part of the ETDRS protocol was supplemented by review of clinic charts for visual acuity and ocular status immediately before vitrectomy. RESULTS: Vitrectomy was performed in 208 (5.6%) of the 3711 patients (243 eyes) enrolled in the ETDRS. The 5-year vitrectomy rates for eyes grouped by their initial photocoagulation assignment were as follows: 2.1% in the early full scatter photocoagulation group, 2.5% in the early mild scatter group, and 4.0% in the deferral group. The 5-year rates of vitrectomy (in one or both eyes) were 5.4% in patients assigned to aspirin and 5.2% in patients assigned to a placebo. The indications for vitrectomy were either vitreous hemorrhage (53.9%) or retinal detachment with or without vitreous hemorrhage (46.1%). Before vitrectomy, visual acuity was 5/200 or worse in 66.7% of eyes and better than 20/100 in 6.2%. One year after vitrectomy, the visual acuity was 20/100 or better in 47.6% of eyes, including 24.0% with visual acuity of 20/40 or better. CONCLUSIONS: With frequent follow-up examinations and timely scatter (panretinal) photocoagulation, the 5-year cumulative rate of pars plana vitrectomy in ETDRS patients was 5.3%. Aspirin use did not influence the rate of vitrectomy.

Adult↗