Objective: To describe the frequency and predictors of local treatment failure and enucleation after iodine 125 (I-125) brachytherapy in patients with choroidal melanoma treated and followed up in a large randomized clinical trial.Design: Prospective, noncomparative, interventional case series within a randomized, multicenter clinical trial.Participants: Patients enrolled in the Collaborative Ocular Melanoma Study (COMS) trial of enucleation versus brachytherapy between February 1987 and July 1998; tumors measured 2.5 to 10.0 mm in apical height and no more than 16.0 mm in longest basal dimension.Methods: 1125 brachytherapy was administered via episcleral plaque according to a standard protocol. Follow-up ophthalmic evaluations, including ophthalmic ultrasound and fundus photography, were performed according to a standard protocol at baseline, every 6 months thereafter for 5 years, and subsequently at annual intervals. Survival analysis methods were used to estimate the cumulative risk of postirradiation treatment failure and enucleation. Factors associated with treatment failure and enucleation of plaqued eyes were evaluated using Cox proportional hazards analysis.Main Outcome Measures: Reports of enucleation and of local treatment failure, defined as tumor growth, recurrence, or extrascleral extension, derived from clinical reports based on echographic and photographic documentation.Results: As of September 30, 2000, 638 of the 650 patients randomized to brachytherapy and so treated had been followed up for 1 year or longer, and 411 had been followed up for at least 5 years. Sixty-nine eyes were enucleated during the first 5 years after brachytherapy, and treatment failure was reported for 57 eyes. The Kaplan-Meier estimate of proportion of patients undergoing enucleation by 5 years was 12.5% (95% confidence interval [Cl], 10.0%-15.6%); the risk of treatment failure was 10.3% (95% Cl, 8.0%-13.2%). Treatment failure was the most common reason for enucleation within 3 years of treatment; beyond 3 years, ocular pain was most common. Risk factors for enucleation were greater tumor thickness, closer proximity of the posterior tumor border to the foveal avascular zone, and poorer baseline visual acuity in the affected eye. Risk factors for treatment failure were older age, greater tumor thickness, and proximity of the tumor to the foveal avascular zone. Local treatment failure was associated weakly with reduced survival after controlling for baseline tumor and personal characteristics (adjusted risk ratio, 1.5; P = 0.08). 1125Conclusions. Local treatment failure and enucleation were relatively infrequent events after brachytherapy within the COMS. Treatment failure typically occurred early and was associated weakly with poorer survival. The COMS randomized trial documented the absence of a clinically or statistically significant difference in survival for patients randomly assigned to enucleation versus brachytherapy. This analysis documents the efficacy of brachytherapy to achieve sustained local tumor control and to conserve the globe. Ophthalmology 2002,109:2197-2206 (C) 2002 by the American Academy of Ophthalmology.
BACKGROUND:As part of the design of the Silicone Study, a new classification of proliferative vitreoretinopathy (PVR) was developed that distinguishes the different types of contraction found in PVR. In contrast to the original Retina Society system that emphasized the post-equatorial retinal pathology (posterior PVR), the Silicone Study classification system included the characteristic types of contraction found in both the equatorial region and the pre-equatorial retina and vitreous base (anterior PVR).METHODS:The authors contrast (1) preoperative and intraoperative findings and (2) vision and anatomic outcomes in the cohort of anterior PVR eyes with the cohort of posterior-only PVR eyes. For the cohort of eyes randomized to perfluoropropane gas (C3F8) or silicone oil, the authors carry out univariate and multivariate analyses to assess the predictive value of baseline and intraoperative parameters on vision and anatomic outcome.RESULTS:Anterior PVR was present in 321 eyes (79%) and was more prevalent in eyes that had undergone an unsuccessful vitrectomy before study entry than in eyes that underwent a primary vitrectomy for PVR (88% versus 73%; P < 0.001). Compared with eyes that had posterior PVR at the preoperative examination, eyes that had anterior PVR tended to (1) be graded (Retina Society classification system) as D-1 or worse (86% versus 49%; P < 0.0001), (2) have worse (< 2/200) visual acuity (93% versus 86%; P = 0.003), (3) have more hypotony (24% versus 11%; P = 0.03), more edema (8% versus 2%; P = 0.04), more aqueous flare (P = 0.02), more macular pucker (69% versus 52%; P = 0.005), and more intravitreal contraction (21% versus 6%; P = 0.002). When compared with eyes that had anterior PVR, eyes with posterior PVR had a better outcome at the 6-month postoperative examination: complete attachment of the retina (76% versus 62%; P = 0.04), visual acuity of 5/200 or better (64% versus 45%; P = 0.006), and normal intraocular pressure (86% versus 71%; P = 0.04). For eyes with anterior PVR, significant predictors of poor (< 5/200) visual acuity were a preoperative PVR grade D-1 or worse and the use of C3F8 gas as the intraocular tamponade.CONCLUSION:The Silicone Study classification of anterior PVR permits greater specificity in characterizing PVR and is prognostic of anatomic and vision outcome. Eyes with anterior PVR and clinically significant posterior PVR changes had a better visual prognosis if silicone oil was used. With the current understanding of the pathoanatomy of anterior PVR and the recent development of new surgical techniques, the incidence of anterior PVR in eyes that previously underwent vitrectomy may decline, and the prognosis in eyes with anterior PVR may improve.
BACKGROUND:The prevalence of postoperative macular pucker and the factors associated with its development after successful surgery for proliferative vitreoretinopathy (PVR) using silicone oil or gas tamponade are unknown. METHODS:The postoperative status of the macula was determined by reviewing the photographs of 336 eyes taken 6 months after randomization. Two hundred eleven eyes with attached maculas were identified and analyzed to determine the prevalence of macular pucker after silicone oil and gas tamponades in eyes without (group 1) and with (group 2) previous vitrectomy surgery. Data obtained at baseline, from the primary study surgery, and from subsequent examinations and repeat surgeries during a follow-up period of 6 months were analyzed for factors associated with postoperative macular pucker. RESULTS:The 6-month-point prevalence rate of postoperative macular pucker was 15% (32 of 211 eyes). Ten of the 32 eyes were new cases of macular pucker. The authors were unable to document a difference in the 6-month-point prevalence of postoperative macular pucker between group 1 and group 2 eyes (13% versus 18%) or between eyes randomized to gas versus silicone oil (19% versus 12%). Postoperative pucker was three times as likely to develop in aphakic/pseudophakic eyes compared with phakic eyes (P = 0.02). Focal contraction posteriorly causing starfolds, and intravitreal contraction involving the vitreous base or vitreous cavity, were significantly less prevalent in eyes with postoperative macular pucker (P < 0.05). Large (> or = 2 disc diameters) retinal breaks (P = 0.04) were associated significantly with postoperative macular pucker (P = 0.04). The authors were unable to document an association between postoperative macular pucker and the type of adhesive modality used or the extent of its application. Postoperative visual acuity was significantly better if the macula was not puckered (P < 0.01). CONCLUSIONS:The occurrence of macular pucker after successful surgery for retinal detachments complicated by severe PVR is not influenced by the choice of intraocular tamponade. Certain preoperative factors may be associated with postoperative macular pucker.
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).
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We evaluated the effect of intraocular silicone oil as an internal tamponade on an animal model of proliferative vitreoretinopathy. Lensectomy and vitrectomy were performed on two groups of pigmented rabbits. Twenty-five rabbit eyes then had 1,000 centistokes' viscosity silicone oil injected into the vitreous cavity; 20 control eyes received balanced salt solution. Fourteen days later, each eye was injected with homologous fibroblasts (ten eyes with 100,000 cells, 25 eyes with 250,000 cells, and ten eyes with 750,000 cells). All membranes that developed after the cell injections in both experimental and control eyes produced traction retinal detachment. The character of the membranes formed and the timing of the traction retinal detachment were the same for both groups. In an active phase of experimental proliferation, the internal tamponade of silicone oil is insufficient to keep the retina in place.
Cataract extraction in patients with chronic uveitis may be hazardous. Recent studies have indicated an improvement in prognosis using lensectomy-vitrectomy techniques in selected cases of uveitic cataracts. The results of lensectomy-vitrectomy in 12 cases of uveitic cataract are reported. All patients had improvement in vision. No significant "flare-up" of the underlying uveitis was found and no patients deteriorated. The importance of extensive preoperative evaluation is emphasized. The major cause of decreased acuity after operation was persistent cystoid macular edema, a complication of chronic inflammation.
Transplantation of from 10,000 to 750,000 autologous and homologous dermal fibroblasts into the vitreous cavity of rabbit eyes resulted in identical clinical findings leading to massive periretinal proliferation. A dose-response relationship between the number of cells injected and the extent of retinal traction that developed was established. The second phase of the experiment evaluated the effects of formalin and cobalt irradiation on the fibroblasts' ability to cause traction retinal detachment. Cell proliferation or the attainment of a critical mass of living cells was necessary for the development of traction retinal detachment.
We used closed-eye endosurgery to treat 58 patients with anterior segment problems. These included nonsenile cataract, residual lens material, pupillary membranes, vitreocorneal touch, aphakic pupillary block glaucoma, intraocular lens complications, epithelial ingrowth, and total hyphema. Thirty-five eyes showed an increase in visual acuity of more than two Snellen lines, 13 eyes demonstrated no change, and ten eyes lost more than two lines. Complications included endophthalmitis, retinal detachment, retinal tears, increased intraocular pressure, postoperative hemorrhage, and bullous keratopathy.
Ocular complications of diabetes in humans are reviewed briefly, and experimental models available for study of the complications are described. Potentially suitable models include not only diabetic animals, but also nondiabetic animals in which analogous lesions have been demonstrated. Many abnormalities of the lens, cornea, iris, and retina comparable to those of diabetes in humans may be observed in diabetic animals, although all abnormalities are not necessarily observed in every species. Retinal changes, in particular, may occur in diabetic animals of several species, but only in large animals (dogs, primates) have saccular capillary aneurysms been reproduced consistently, together with other retinal changes typical of diabetes in humans. A few examples of the uses of animal models are offered, and attention is called to a lack of animal models of proliferative diabetic retinopathy and of rubeosis iridis.
We use a soft contact lens with a central depression into which a hard contact lens can be fitted to simulate conditions that cause decreased visual acuity. This "piggy-back" system can simulate central scotoma, various peripheral field defects, and opacities of the media.
SUMMARY We describe a new, safe technique for removing posteriorly located magnetic intraocular foreign bodies. The technique consists of magnetizing an intraocular instrument by placing an electromagnet against the extraocular portion. After a vitrectomy, the magnetized instrument lifts the foreign body anteriorly in a controlled fashion, and removes the object through the pars plana. Its use is illustrated in two case reports.
We evaluated the effect of scleral buckling procedures on uveal blood flow in rabbits by injection of microspheres labeled with strontium 85. Cerclage reduced both anterior and posterior uveal blood flow, and removing the cerclage returned the blood flow to normal. Sham cerclage and local scleral buckle did not decrease blood flow.
We used new applications for a pars plana infusion cannula in three patients with retinal and choroidal detachments. Because the cannula maintained intraocular volume and form, it was helpful in treatment bullous retinal detachment and choroidal detachment.
Two patients underwent vitrectomy with the use of intraocular gas. In one patient the cornea decompensated because of lens-cornea contact and in the second patient a surgical technique devised to protect the cornea from lens contact was used successfully. The technique consisted of injecting a smaller gas bubble into the anterior chamber before the instillation of the posterior chamber gas.