Early Post Operative Complications and Results in Ex-PRESSTM Shunt versus Trabeculectomy

Abstract

Purpose: : To examine early post-operative surgical outcomes in patients undergoing Ex-PRESS^TM shunt versus trabeculectomy (trab) with mitomycin-C

Methods: : A randomized prospective study of patients treated between January 1, 2008 and September 1, 2008 with either Ex-PRESS^TM shunt or trab for uncontrolled glaucoma. Fifteen patients (8 Ex-PRESS^TM, 7 trab) were examined post-operatively at 1 day, 1 week, 2 week, 1 month, and 2 month visits with additional visits as deemed necessary. Early (within 2 months) post-operative outcomes were examined, including intraocular pressure (IOP), visual acuity (LogMAR VA), and post-operative complications.

Results: : IOP dropped significantly in both Ex-PRESS^TM (p=0.003) and trab patients (p=0.0001). Mean IOP decreased after Ex-PRESS^TM (-11.9 mm Hg) and trab (-17.7 mm Hg). Mean percentage of IOP decrease was -51.5% for Ex-PRESS^TM and -74.7% for trab patients (p=0.038). LogMAR VA worsened in patients undergoing Ex-PRESS^TM (0.25) and trab (0.11), (p=0.171). The incidence of bleb leak, hyphema, and persistent iritis were the same in both groups. Choroidal detachments were noted in 2 Ex-PRESS^TM patients and 3 trab patients, despite the difference in IOP between the two groups. Three Ex-PRESS^TM patients, and 7 trab patients experienced hypotony (IOP<5) during the first 2 months.

Conclusions: : All patients had post-operative IOP lowering with discontinuation of all topical glaucoma medicines. Trab patients had greater IOP reduction and a significantly greater mean percentage IOP decrease than Ex-PRESS^TM patients. Both groups experienced visual acuity decline within the early post-operative period. There was no difference in early post-operative complications of bleb leak, hyphema, or persistent iritis between the two groups. Choroidal detachments were detected in similar frequency in both subsets. Trab patients had a 2.5 times higher incidence of hypotony during the early post-operative period, but that difference resolved by 2 months. The Ex-PRESS^TM shunt demonstrates significant early IOP control without increased post-operative complications, and appears to be a reasonable alternative to trabeculectomy.

Clinical Trial: : www.clinicaltrials.gov NCT00597181

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • clinical (human) or epidemiologic studies: outcomes/complications • intraocular pressure