Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema.

OBJECTIVE: To assess the efficacy and safety of intravitreal inserts releasing 0.2 µg/day (low dose) or 0.5 µg/day (high dose) fluocinolone acetonide (FA) in patients with diabetic macular edema (DME). DESIGN: Two parallel, prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trials. PARTICIPANTS: Subjects with persistent DME despite at least 1 macular laser treatment were randomized 1:2:2 to sham injection (n = 185), low-dose insert (n = 375), or high-dose insert (n = 393). METHODS: Subjects received study drug or sham injection at baseline and after 6 weeks were eligible for rescue laser. Based on retreatment criteria, additional study drug or sham injections could be given after 1 year. MAIN OUTCOME MEASURES: The primary outcome was the percentage of patients with improvement from baseline best-corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy Trial (ETDRS) letter score of 15 or more at month 24. Secondary outcomes included other parameters of visual function and foveal thickness (FTH). RESULTS: The percentage of patients with improvement from baseline ETDRS letter score of 15 or more at month 24 was 28.7 and 28.6 in the low- and high-dose insert groups, respectively, compared with 16.2 in the sham group (P = 0.002 for each). Benefit occurred for both doses compared with sham at 3 weeks and all subsequent time points. The mean improvement in BCVA letter score between baseline and month 24 was 4.4 and 5.4 in the low- and high-dose groups, respectively, compared with 1.7 in the sham group (P = 0.02 and P = 0.016). At all time points compared with sham, there was significantly more improvement in FTH. Subjects requiring cataract surgery were more frequent in the insert groups, and their visual benefit was similar to that of subjects who were pseudophakic at baseline. Glaucoma requiring incisional surgery occurred in 3.7%, 7.6%, and 0.5% of the low-dose, high-dose, and sham groups, respectively. CONCLUSIONS: Both low- and high-dose FA inserts significantly improved BCVA in patients with DME over 2 years, and the risk-to-benefit ratio was superior for the low-dose insert. This is the first pharmacologic treatment that can be administered by an outpatient injection to provide substantial benefit in patients with DME for at least 2 years.

Purtscher's retinopathy: a case report and review.

A case of posttraumatic loss of vision was seen in the emergency department that was diagnosed as Purtscher's retinopathy or traumatic retinal angiopathy. Purtscher's retinopathy presents as an acute loss of vision after a traumatic event or as a sequelae of another disease process. The case is presented with a discussion of the pathophysiology, diagnosis, prognosis, and treatment options for this entity.

Office-based sutureless transconjunctival pars plana vitrectomy.

PURPOSE: This is a preliminary report to describe our technique of office-based vitrectomy (OVIT) and to report the incidence of complications over a 6-year period. METHODS: In a retrospective, noncomparative case series, OVIT was performed on 225 patients in four participating offices. Each patient was operated on with a 23-gauge vitreous cutter that the authors have developed. They have also developed a 23-gauge transconjunctival infusion needle device. Diagnoses included endophthalmitis, uveitis, intravitreal lens fragments, ghost cell glaucoma, and rhegmatogenous retinal detachment. RESULTS: The surgical goal was accomplished in all cases, but supplemental office procedures were required for two eyes, and a scleral buckle was necessary in one eye. There were 15 complications in 14 eyes: "fish-egg" gas bubbles (one eye), intraocular hemorrhage (nine eyes), choroidal detachment (two eyes), new retinal breaks (one eye), retinal detachment (one eye), and temporary elevation of intraocular pressure (one eye). The hemorrhages, choroidal detachments, and fish-egg bubbles all resolved spontaneously. CONCLUSION: Office-based sutureless transconjunctival pars plana vitrectomy, with infusion when needed, is an effective operation for selected diseases of the posterior segment. In a multicenter series of 225 eyes, there were 15 complications in 14 (6%) eyes. Two of the complications were successfully managed with additional office procedures; one was managed in the operating room; and 12 resolved spontaneously.