Ex-PRESS R-50 miniature glaucoma implant insertion under the conjunctiva combined with cataract extraction

Abstract

To evaluate the efficacy and safety of the Ex-PRESS R-50 implant (Optonol Ltd.) in eyes operated on for open-angle glaucoma combined with phacoemulsification. Glaucoma Unit, Ophthalmology Department, University of Lausanne, Lausanne, Switzerland. Between November 2000 and June 2002, the Ex-PRESS R-50 shunt was implanted in 35 eyes of 35 patients. The best corrected visual acuity (BCVA), intraocular pressure (IOP), number of medications, and complications were recorded preoperatively as well as postoperatively at 1 and 7 days and 1, 2, 3, 6, 9, 12, 24, 36, and 48 months. Temporal clear corneal phacoemulsification with intraocular lens implantation was performed first. The ophthalmic viscosurgical device was not removed, and the Ex-PRESS R-50 was implanted under the conjunctiva into the anterior chamber. The mean follow-up was 36.9 months +/- 18.2 (SD) and the mean age of the patients, 74.6 +/- 10.9 years. The mean preoperative IOP of 19.3 +/- 6.3 mm Hg decreased postoperatively to 15.3 +/- 6.2 mm Hg, 15.1 +/- 4.6 mm Hg, 13.8 +/- 2.8 mm Hg, 14.6 +/- 2.9 mm Hg, and 13.3 +/- 2.0 mm Hg at 6 months, 12 months, 24 months, 36 months, and 48 months, respectively (P<.005). At 48 months, the mean BCVA was 0.74 +/- 0.34 and the number of medications was reduced by 57% (P<.005). The microtube was removed in 10 patients, and bleb management was performed in 10 eyes. Ten patients (32%) had satisfactory IOP control (mean 13.2 +/- 2.2 mm Hg) without medication; minor transient complications were observed in 10 patients. Based on the cumulative survival curve after 48 months, the complete success rate was 32.7% and the qualified success rate, 53.7% (P<.05). Ex-PRESS R-50 implantation under the conjunctiva was associated with a relatively high number of complications, despite good IOP control in the uncomplicated cases. Refinement in the tube design and implantation technique would increase the success rate.