Five-Year, Prospective, Randomized, Multi-Surgeon Trial of Two Trabecular Bypass Stents versus Prostaglandin for Newly Diagnosed Open-Angle Glaucoma.

Ophthalmology. Glaucoma
Robert D FechtnerHady Saheb

Abstract

To evaluate 5-year safety and efficacy of 2 trabecular micro-bypass stents versus prostaglandin as initial stand-alone treatment for newly diagnosed, treatment-naive primary open-angle glaucoma (POAG). Prospective, randomized, controlled, multi-surgeon clinical trial. Enrolled eyes (n = 101) were phakic and had a confirmed POAG diagnosis, normal angle anatomy, mean diurnal intraocular pressure (IOP) 21 to 40 mmHg, and vertical cup-to-disc (C:D) ratio ≤0.9. Eyes were randomized (1:1) to receive either 2 stents (iStent trabecular micro-bypass; Glaukos Corporation, San Clemente, CA) or once-daily topical travoprost. The primary and secondary efficacy end points were the change from screening in mean diurnal IOP at months 12 and 24, respectively, without glaucoma surgery or add-on medication (any medication in stent eyes or a second medication in travoprost eyes). Two additional secondary end points were the proportion of eyes achieving treatment success at months 12 and 24, defined as IOP 6 to 18 mmHg without additional medication or glaucoma surgery. This report shows these efficacy measures through 60 months. Safety measures included best-corrected visual acuity, C:D ratio, visual field, pachymetry, complications, and adverse ev...Continue Reading

Citations

Sep 17, 2020·Annual Review of Vision Science·David J Mathew, Yvonne M Buys
Sep 29, 2020·Clinical Ophthalmology·Ciro CostagliolaAntonio Maria Fea
Aug 24, 2019·Advances in Therapy·Ricardo Augusto Paletta GuedesAlfredo Chaoubah
Dec 15, 2020·Current Opinion in Ophthalmology·Kateki Vinod, Steven J Gedde
Jun 21, 2020·Progress in Retinal and Eye Research·Gordana Sunaric Megevand, Alain M Bron
May 14, 2021·Clinical Ophthalmology·Ricardo Augusto Paletta GuedesAlfredo Chaoubah
Jun 8, 2021·Ophthalmology. Glaucoma·Matt Schlenker, Vinay Kansal

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