PURPOSE: To evaluate the relationship between microbiologic factors, effect of treatment, and visual outcome in the Endophthalmitis Vitrectomy Study.METHODS: Four hundred twenty patients were enrolled in the Endophthalmitis Vitrectomy Study between February 1990 and January 1994. Of these, 394 completed 9 to 12 months of follow-up. Patients presented with features of bacterial endophthalmitis within 6 weeks of cataract extraction or secondary intraocular lens implantation. The relations between visual outcome and the identity of infecting species, gram stain results, antibiotic susceptibilities, and presence of vitrectomy cassette growth were examined.RESULTS: Rates of achieving final visual acuity of 20/100 or better for the more common isolates were as follows: gram-positive, coagulase-negative micrococci, 84%; Staphylococcus aureus, 50%; streptococci, 30%; enterococci, 14%; and gram-negative organisms, 56%. A positive gram stain or infection with species other than gram-positive, coagulase-negative micrococci were significantly associated with poorer visual outcome (P <.001 for species group comparisons). However, presenting visual acuity was more powerful than microbiologic factors in predicting visual outcome and favorable response to vitrectomy. Bacterial growth from the vitrectomy cassette specimen had prognostic significance equivalent to growth from other intraocular sources.CONCLUSIONS: Visual prognosis was strongly associated with the type of infecting organism and gram stain positivity. However, visual acuity at initial presentation appeared to be more useful than microbiologic factors in predicting visual outcome and judging the value of immediate vitrectomy in acute bacterial endophthalmitis after cataract surgery.
Objective: To describe the clinical characteristics and survival experience of a prospectively followed up group of patients with small choroidal melanoma.Methods: The Collaborative Ocular Melanoma Study (COMS) is a set. of clinical trials designed to compare the role of radiotherapy and enucleation in the treatment of medium and large-size choroidal melanoma. From December 1986 to August 1989, patients with small choroidal melanoma, not large enough to be eligible for the COMS clinical trials, were offered participation in a nonrandomized prospective follow-up study. Small choroidal melanomas were defined as 1.0 to 3.0 mm in apical height and al least 5.0 mm in basal diameter. A total of 204 patients were enrolled in the study. Patients were followed up annually through August 1989. Two additional assessments of treatment status and mortality were conducted in 1993-1994 and 1995-1996. The median length of follow-up was 92 months. Eight percent of patients were treated at the time of study enrollment and an additional 33% were treated during follow-up.Results: Twenty-seven patients have died; 6 deaths were reported by the clinical center as due to metastatic melanoma. The Kaplan-Meier estimate of 5-year all-cause mortality was 6.0% (95% confidence interval, 2.7%-9.3%) and 8-year all-cause mortality was 14.9% (95% confidence interval, 9.6%-20.2%).Conclusions: Otherwise healthy patients, average age of GO years, without a previous diagnosis of malignant disease who have small choroidal lesions judged to be melanoma have a low risk of dying within 5 years.
Objective: To determine the roles of immediate pars plana vitrectomy (VIT) and systemic antibiotic treatment in the management of postoperative endophthalmitis.Design: Investigator-initiated, multicenter, randomized clinical trial.Setting: Private and university-based retina-vitreous practices.Patients: A total of 420 patients who had clinical evidence of endophthalmitis within 6 weeks after cataract surgery or secondary intraocular lens implantation.Interventions: Random assignment according to a 2 X 2 factorial design to treatment with VIT or vitreous tap or biopsy (TAP) and to treatment with or without systemic antibiotics (ceftazidime and amikacin).Main Outcome Measures: A 9-month evaluation of visual acuity assessed by an Early Treatment Diabetic Retinopathy Study acuity chart and media clarity assessed both clinically and photographically.Results: There was no difference in final visual acuity or media clarity with or without the use of systemic antibiotics. In patients whose initial visual acuity was hand motions or better, there was no difference in visual outcome whether or not an immediate VIT was performed. However, in the subgroup of patients with initial light perception-only vision, VIT produced a threefold increase in the frequency of achieving 20/40 or better acuity (33% vs 11%), approximately a twofold chance of achieving 20/100 or better acuity (56% vs 30%), and a 50% decrease in the frequency of severe visual loss (20% vs 47%) over TAP. In this group of patients, the difference between VIT and TAP was statistically significant (P < .001, log rank test for cumulative visual acuity scores) over the entire range of vision.Conclusions: Omission of systemic antibiotic treatment can reduce toxic effects, costs, and length of hospital stay. Routine immediate VIT is nor necessary in patients with better than light perception vision at presentation but is of substantial benefit for those who have light perception-only vision.
The Collaborative Corneal Transplantation Studies (CCTS) is a set of two multicenter clinical trials designed to investigate the efficacy of donor-recipient human leukocyte antigen matching and crossmatching. High-risk penetrating keratoplasty patients were enrolled through six clinical centers for either the Antigen Matching Study or the Crossmatch Study. All patients were subject to a common set of examinations, treatments, and evaluation procedures. Standard procedures for the identification of high-risk patients, administration of postoperative medications, and recognition and treatment of immunologic allograft reactions were developed and used successfully. These procedures may serve as guidelines for studies in corneal transplantation. Adoption of these methods by other investigators would facilitate evaluation and comparison of results.
Between September 1985 and September 1987, 101 eyes with rhegmatogenous retinal detachment and severe (with a classification of at least C-3) proliferative vitreoretinopathy but without prior vitrectomy were treated with vitrectomy and randomized to either a mixture of 20% sulfur hexafluoride gas and air or to 1 000 centistokes of silicone oil. Between 50% and 60% of eyes that received silicone oil had visual acuity better than or equal to 5/200 compared with 30% to 40% of the eyes that received sulfur hexafluoride gas (P<.05). Macula attachment was more frequent in eyes that received silicone oil than in those that received sulfur hexafluoride gas (80% vs 60%, P<.05). Hypotony was more prevalent in eyes with a detached macula (40% to 50% for sulfur hexafluoride gas vs 25% to 30% for silicone oil) when compared with those with attached maculas (<5% for either modality). Keratopathy was more prevalent in eyes with detached maculas (about 55% to 60% for either modality) compared with eyes with attached maculas (25% to 30% for sulfur hexafluoride gas vs 10% to 15% for silicone oil). In a companion article, we show that these differences between a gas tamponade and silicone oil are not found for perfluoropropane gas.
Between September 1987 and October 1990, 265 eyes with rhegmatogenous retinal detachment and severe (with a classification of at least C-3) proliferative vitreoretinopathy were treated with vitrectomy and randomized to treatment with perfluoropropane gas or silicone oil; 131 eyes had undergone no prior vitrectomy (group 1) while 134 eyes had undergone vitrectomy with intraocular gas tamponade (group 2). At the last examination, there were no differences between perfluoropropane gas and silicone oil in achieving visual acuity greater than or equal to 5/200 (43% vs 45% for group 1, 38% vs 33% for group 2) and complete posterior retinal reattachment (73% vs 64% for group 1, 73% vs 61% for group 2). For group 1 eyes followed up for at least 18 months, there was an advantage favoring perfluoropropane gas in achieving complete posterior retinal reattachment (83% vs 60% at 36 months, P=.045). The rates of reoperation and keratopathy were similar, while hypotony was more prevalent in eyes randomized to perfluoropropane gas (group 2). Regardless of tamponade, groups 1 and 2 had similar anatomic and visual success. However, hypotony was twice as prevalent in group 2 (perfluoropropane), and the prevalence of keratopathy increased with follow-up in group 2 (either tamponade). Either tamponade produced better results than those seen with sulfur hexafluoride gas (Silicone Study Report 1).
The Collaborative Corneal Transplantation Studies (CCTS) were designed to evaluate the effect of donor-recipient histocompatibility matching and crossmatching on the survival of corneal transplants in high-risk patients. Corneas were allocated to the 419 patients in the double-masked Antigen Matching Study on the basis of serologically defined HLA-A, -B and HLA-DR antigen match. ABO blood group compatibility was determined but not used for recipient selection. The 37 patients in the Crossmatch Study were randomly assigned to receive a cornea from either a positively or negatively crossmatched donor. All patients received topical steroid therapy according to a standard protocol. Matching for HLA-A, -B and HLA-DR antigens had no effect on overall graft survival, the incidence of irreversible rejection, or the incidence of rejection episodes. At 3 years after surgery, the estimated proportion of eyes with graft failure was 41% for the ABO-incompatible group and 31% for the ABO-compatible group (relative risk, 1.43; 95% confidence interval, 1.00 to 2.06). The estimated proportion of eyes with failure from rejection by 3 years was 30% for the ABO-incompatible group and 16% for the ABO-compatible group (relative risk, 1.98; 95% confidence interval, 1.25 to 3.13). The positive group in the Crossmatch Study had fewer graft failures, rejection failures, and rejection episodes than the negative group; however, these differences were not statistically significant. These studies demonstrate that, for high-risk patients who are immunosuppressed by topical steroid therapy and followed up according to the CCTS protocol: (1) neither HLA-A, -B nor HLA-DR antigen matching substantially reduces the likelihood of corneal graft failure; (2) a positive donor-recipient crossmatch does not dramatically increase the risk of corneal graft failure; and (3) ABO blood group matching, which can be achieved with relatively little effort and expense, may be effective in reducing the risk of graft failure.
The Silicone Study is a multicentered, randomized surgical trial designed to compare the tamponade effectiveness of silicone oil versus long-acting gas in the treatment of proliferative vitreoretinopathy (PVR) by vitrectomy and associated techniques. Fundus photographs are taken to provide documentation of the anatomic status of eyes proposed for entry and are graded at an independent Reading Center. This article describes the protocol for photographic documentation of PVR as a continuum of increasing pathology, in which the pathology may only be present in the anterior retina, and the retina is usually highly elevated. In a validity and reliability study, agreement between photographic and clinical observation within one step was obtained for 88% of the eyes; intra- and inter-observer agreement within one step was 85 and 80%, respectively. Differences between the surgeon's grade and the Reading Center's were caused about equally by disagreement regarding extent of fixed folds and width of the funnel. Rarely did peripheral folds not visible in the photographs appear to be the sole explanation of the disagreement. Differences among readers were concerned mainly with differentiation of true full-thickness fixed folds from folds due to simple redundancy of the detached retina. These results demonstrate that complicated retinal detachment (RD) can be photographically documented and independently assessed.
We performed a clinical evaluation on a prototype version of the Tono-Pen hand-held tonometer. A masked, randomized design was used to compare the instrument with the Goldmann tonometer. We tested 270 eyes. For pressures of 6 to 24 mm Hg, the Tono-Pen tonometer measured, on average, 1.7 mm Hg higher than the Goldmann tonometer. This difference was statistically significant (P less than .0001). In the range above 24 mm Hg, no statistically significant difference was found in the pressures measured with the two instruments. Measurements made with the Tono-Pen were sufficiently close to those made with the Goldmann tonometer to be considered clinically accurate.