| Abstrakt: |
aime E Dickerson Jnr8,91The Williamson Eye Center, Baton Rouge, LA, USA; 2Vold Vision, Fayetteville, AR, USA; 3Grene Vision Group, Wichita, KS, USA; 4Mercy Eye Specialists, Springfield, MO, USA; 5Buffalo Ophthalmology, Williamsville, NY, USA; 6Morris Eye Group, Encinitas, CA, USA; 7Arthur M Cotliar Eye Care and Surgery, New York, NY, USA; 8North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TX, USA; 9Sight Sciences, Inc., Menlo Park, CA, USACorrespondence: Jaime E Dickerson Jnr, Email [email protected] Purpose: To provide extended safety and effectiveness follow-up for eyes treated with circumferential canaloplasty and trabeculotomy (CP+TR) that were included in the 12-month ROMEO study. Setting: Seven multi-subspecialty ophthalmology practices located in 6 states (Arkansas, California, Kansas, Louisiana, Missouri, and New York). Design: Retrospective, multicenter, IRB approved. Subjects: Eligible eyes had mild–moderate glaucoma and were treated with CP+TR with cataract surgery or as a standalone intervention. Methods: Main outcome measures were mean IOP, mean number of ocular hypotensive medications, mean change in number of medications, proportion of patients with a ≥ 20% reduction in IOP or with IOP ≤ 18 mmHg, and proportion of patients medication free. Safety outcomes were adverse events and secondary surgical interventions (SSI). Results: Eight surgeons at 7 centers contributed 72 patients stratified by pre-operative intraocular pressure (IOP); > 18 mmHg (Grp1), ≤ 18 mmHg (Grp2). Mean follow-up of 2.1 years (min 1.4, max 3.5). 2-year IOP (SD) was 15.6 mmHg (− 6.1 mmHg, − 28% from baseline) on 1.4 medications (− 0.9, − 39%) for Grp1 with cataract surgery; 14.7 mmHg (− 7.4 mmHg, − 33% from baseline) on 1.6 medications (− 0.7, − 15%) for Grp1 standalone, 13.7 mmHg (− 0.6 mmHg, − 4.2%) on 1.2 medications (− 0.8, − 35%) for Grp2 with cataract surgery, 13.3 mmHg (− 2.3 mmHg, − 14.7%) on 1.2 medications (− 1.0, − 46%) for Grp2 standalone. The proportion of patients at 2 years with either a ≥ 20% IOP reduction or IOP between 6 and 18 mmHg and no increase in medication or SSI was 75% (54 of 72, 95% CI 69.9%, 80.1%). One-third of patients (24 of 72) were medication free whereas 9 of 72 were pre-surgical. No device-related adverse events during extended follow-up; 6 eyes (8.3%) required additional surgical or laser intervention for IOP control after 12 months. Conclusion: CP+TR provides effective IOP control that is sustained for 2 years or more. [ABSTRACT FROM AUTHOR] |
