George Reiss1, Bill Clifford2, Steven Vold3, Jonathan He4, Cody Hamilton4, Jaime Dickerson5, Stephen Lane6. 1. Eye Physicians and Surgeons of Arizona, Scottsdale, Arizona, USA. 2. Fry Eye Associates, Fort Worth, Texas, USA. 3. Vold Vision, Fayetteville, Arkansas, USA. 4. Alcon Research LLC, Fort Worth, Texas, USA. 5. Alcon Research LLC, Fort Worth, Texas, USA; North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, Texas, USA. 6. Alcon Research LLC, Fort Worth, Texas, USA; Department of Ophthalmology, University of Minnesota, Minneapolis, Minnesota, USA. Electronic address: stephen.lane@alcon.com.
Abstract
PURPOSE: To characterize the long-term (up to 5 years) safety and effectiveness of the supraciliary Micro-Stent (Alcon) implanted at the time of phacoemulsification in eyes with coexisting open-angle glaucoma (OAG) and visually significant cataract. DESIGN: Three-year safety extension of a 2-year randomized clinical trial. METHODS: Patients from the multicenter Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma PatientsUndergoing Cataract Surgery (COMPASS) trial who underwent Micro-Stent implantation plus phacoemulsification (n = 215) or phacoemulsification alone (n = 67) were evaluated 36, 48, and 60 months postoperatively. The primary outcome measurement was the occurrence of sight-threatening ocular adverse events. Evaluations at each time point included best-corrected visual acuity (BCVA), anterior and posterior segment examinations, tonometry, gonioscopy, pachymetry, perimetry, specular microscopy, and assessment of adverse events. RESULTS: Three sight-threatening ocular adverse events occurred, 2 in the Micro-Stent group and 1 in the control group, but none of these events was related to the Micro-Stent device. Ocular adverse events were of similar frequencies in both groups, the most common of which were BCVA loss of ≥2 lines compared with best BCVA in COMPASS and worsening of visual field mean defect (VFMD) ≥2.5 dB compared with month 24. Changes in mean BCVA from baseline, clinical examinations, pachymetry, and VFMD were similar in the 2 groups. At 60 months, a higher proportion of subjects in the Micro-Stent group (46%; 95% confidence interval [CI], 38.9%-53.2%) than in the control group (32.1%; 95% CI 19.9%-46.3%) were able to achieve a reduction of ≥20% in intraocular pressure without using hypotensive medication. CONCLUSIONS: Few sight-threatening serious ocular adverse events occurred following Micro-Stent implantation, and clinical evidence of corneal decompensation was minimal.
RCT Entities:
PURPOSE: To characterize the long-term (up to 5 years) safety and effectiveness of the supraciliary Micro-Stent (Alcon) implanted at the time of phacoemulsification in eyes with coexisting open-angle glaucoma (OAG) and visually significant cataract. DESIGN: Three-year safety extension of a 2-year randomized clinical trial. METHODS:Patients from the multicenter Study of an Implantable Device for Lowering Intraocular Pressure in GlaucomaPatients Undergoing Cataract Surgery (COMPASS) trial who underwent Micro-Stent implantation plus phacoemulsification (n = 215) or phacoemulsification alone (n = 67) were evaluated 36, 48, and 60 months postoperatively. The primary outcome measurement was the occurrence of sight-threatening ocular adverse events. Evaluations at each time point included best-corrected visual acuity (BCVA), anterior and posterior segment examinations, tonometry, gonioscopy, pachymetry, perimetry, specular microscopy, and assessment of adverse events. RESULTS: Three sight-threatening ocular adverse events occurred, 2 in the Micro-Stent group and 1 in the control group, but none of these events was related to the Micro-Stent device. Ocular adverse events were of similar frequencies in both groups, the most common of which were BCVA loss of ≥2 lines compared with best BCVA in COMPASS and worsening of visual field mean defect (VFMD) ≥2.5 dB compared with month 24. Changes in mean BCVA from baseline, clinical examinations, pachymetry, and VFMD were similar in the 2 groups. At 60 months, a higher proportion of subjects in the Micro-Stent group (46%; 95% confidence interval [CI], 38.9%-53.2%) than in the control group (32.1%; 95% CI 19.9%-46.3%) were able to achieve a reduction of ≥20% in intraocular pressure without using hypotensive medication. CONCLUSIONS: Few sight-threatening serious ocular adverse events occurred following Micro-Stent implantation, and clinical evidence of corneal decompensation was minimal.
Authors: Lisa Hübner; U Schlötzer-Schrehardt; J M Weller; B Hohberger; C Y Mardin; R Lämmer Journal: Graefes Arch Clin Exp Ophthalmol Date: 2022-03-09 Impact factor: 3.535
Authors: Inês C F Pereira; Rosanne van de Wijdeven; Hans M Wyss; Henny J M Beckers; Jaap M J den Toonder Journal: Eye (Lond) Date: 2021-06-14 Impact factor: 3.775