Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study
| Autor: | Jeremy Cotliar, Blake K. Williamson, Sebastian Heersink, Mark J. Gallardo, Michael Hochman, Jaime E. Dickerson, Steven D. Vold, Andrew Cho, Cade Nelson, Anita Campbell, Gabriel Ferreira, Ardalan E. Aminlari, Ryan Phan, Louis Hirsch, Deepan Selvadurai |
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| Rok vydání: | 2020 |
| Předmět: |
Intraocular pressure
medicine.medical_specialty genetic structures Open angle glaucoma medicine.medical_treatment Glaucoma Trabeculectomy Cataract 03 medical and health sciences 0302 clinical medicine Ophthalmology medicine Humans Hyphema Intraocular Pressure Retrospective Studies business.industry Retrospective cohort study Cataract surgery medicine.disease Trabeculotomy eye diseases Sensory Systems Treatment Outcome 030221 ophthalmology & optometry Surgery business 030217 neurology & neurosurgery Glaucoma Open-Angle |
| Zdroj: | Journal of cataract and refractive surgery. 47(7) |
| ISSN: | 1873-4502 |
| Popis: | PURPOSE To provide safety and effectiveness outcomes 12 months postsurgically for sequential canaloplasty and trabeculotomy with the OMNI system combined with cataract surgery in mild-to-moderate open-angle glaucoma (OAG). SETTING Eleven ophthalmology practices and surgery centers located in 8 U.S. states. DESIGN Retrospective, multicenter, single arm. METHODS Twelve surgeons contributed 81 patients meeting eligibility criteria: OAG, 12-month follow-up, and medicated intraocular pressure (IOP) 36 mm Hg or less on 4 or less medications preoperatively. Analysis was stratified by baseline IOP: more than 18 mm Hg (Group 1) and 18 mm Hg (Group 2) or less. Success was defined as proportion with 20% reduction or greater in IOP or IOP between 6 and 18 mm Hg (inclusive) and on the same or fewer medications without secondary surgical intervention (SSI). Other endpoints included mean IOP and medications at 12 months. Safety included corrected distance visual acuity and adverse events (AEs). RESULTS Of the 81 patients included, primary success was met by 79% in Group 1 and 81% in Group 2. The mean IOP was reduced in Group 1 (21.9 to 15.1 mm Hg, P < .0001) and remained controlled in Group 2 (14.1 to 13.4 mm Hg, P = .3177). Medications went from 2.0 ± 1.3 to 1.1 ± 1.1 in Group 1 and from 1.6 ± 1.3 to 0.9 ± 1.2 in Group 2. AEs were typical for cataract or angle surgery: mild inflammation (11%), IOP spikes (5%), and hyphema (4%). Four patients (5%) required an SSI. CONCLUSIONS The OMNI system provided effective IOP reduction, sustained IOP control, and meaningful medication reduction for up to 12 months postoperative. |
| Databáze: | OpenAIRE |
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