Abstract
Purpose: :
To evaluate the long term safety and efficacy of the ExPRESS device implantation under a scleral flap in glaucoma patients.
Methods: :
Non-randomized prospective study. Outcome measures included intra-ocular pressure, number of anti-glaucoma medications, complications and success rate with a follow-up period of four years.
Results: :
Ninety-seven eyes of 72 patients with open-angle glaucoma (OAG) were implanted under a scleral flap with the ExPRESS miniature glaucoma device. Thirty-three eyes (34%) had the surgery combined with cataract extraction and intra-ocular lens implantation. Thirty-eight eyes (39%) had received previous glaucoma surgery. There were 52 Caucasians, 17 Africans, 19 Indians, 2 Asians and 7 of Mixed and unknown race in the group. Mean IOP (±SD) dropped from 29.9 mmHg ±8.8 (n=96) preoperatively to 14.4 ± 2.9 mmHg (n=59), 14.4 ± 3.5 (n=34), and 14.6 ± 3.1 (n=12 ) at 2, 3, and 4 years, respectively. The drop in IOP was significant between baseline and all time points (t-test, p=0.000). Mean number of medications dropped significantly from 2.72 ± 1.26 mmHg preoperatively to 0.68 ± 0.25, 0.33 ± 0.48, and 0.31 ± 0.63 at 2, 3, and 4 years respectively (p=0.01 after 4 years). Twelve eyes required surgery for procedure-related problems (5 AC release, 3 device exchanges, 3 flap revisions, and 1 cataract extraction).Qualified success (IOP≤18 mmHg with or without anti-glaucoma medications) were 90%, 83.3% and 73.3% at 2, 3 and 4 years, respectively.
Conclusions: :
Implanting the Ex-PRESS miniature glaucoma device under a scleral flap resulted in good IOP control, with significant reduced anti-glaucoma medication and high success rate after 4 years of follow-up
Keywords: intraocular pressure • neuroprotection • wound healing