Abstract
Abstract: :
Purpose: The ExPRESS, is a new glaucoma drainage device originally developed for implantation under the conjunctiva in simple open angle glaucoma (OAG). Implanting the ExPRESS under a scleral flap can add safety, efficacy and simplicity in high–risk (refractory) cases. Compared to a trabeculectomy, there is no tissue removal and no need for an iridectomy. We report our interim results with this device with respect to its efficacy and safety in high–risk cases. Methods: A prospective non–randomized study was performed. Outcome measures included intra–ocular pressure, number of anti–glaucoma medications and complications. Post–operative measures of success and measures of short–term and long–term failure were recorded. The study was approved by the Ethics Committee of the University of the Witwatersrand, Johannesburg, South Africa. Results: Twenty–four eyes of 23 patients with complicated OAG (9 Caucasians with a history of at least 1 filtering surgery; 8 Africans; 5 Indians; 1 Mixed race) were implanted under a scleral flap with the ExPRESS miniature glaucoma device. Mean (±SD) follow–up was 63.9±37.7 weeks; 13 eyes completed 1 year, 5 eyes completed 2 years. Mean intra–ocular pressure (IOP) dropped from 27.2±6.9 mmHg to 13.7±2.7mmHg at 1 year post–operatively. IOP reduction was45.8%±13.4. The complete success rate (IOP≤18 mmHg without antiglaucoma medications) was 92.3% at 1–year post–operatively. The number of anti–glaucoma medications dropped from 1.3 to 0.2 medications per patient. Short–term complications included transient hypotony (IOP≤5 mmHg) in three cases (1 shallow anterior chamber (AC), 2 choroidal detachments) which resolved spontaneously within a few days. Long–term complications consisted of 1 eye with continuous IOP≤5 mmHg but with a deep AC, 2 cases of device–iris touch, which required device repositioning, and 1 hyphema that needed surgical drainage. A cystic bleb was observed in 1 eye 3 months post–operatively. Conclusion:Implanting the ExPRESS miniature glaucoma device under a scleral flap in high–risk (refractory) cases was simple and effective. At one year the IOP was controlled without medications in the majority of the cases. Continued follow–up is warranted.
Keywords: clinical (human) or epidemiologic studies: outcomes/complications • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • intraocular pressure