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Abstract #108739 Published in IGR 23-4
First-in-Human Safety Study of Femtosecond Laser Image-Guided Trabeculotomy for Glaucoma Treatment: 24-month Outcomes
Nagy ZZ; Kranitz K; Ahmed IIK; De Francesco T; Mikula E; Juhasz TOphthalmology science 2023; 3: 100313
PURPOSE: Pilot study to evaluate adverse events and intraocular pressure (IOP)-lowering of a novel, noninvasive glaucoma procedure, femtosecond laser, image-guided, high-precision trabeculotomy (FLIGHT). DESIGN: Prospective, nonrandomized, single-center, interventional, single-arm clinical trial. PARTICIPANTS: Eighteen eyes from 12 patients with open-angle glaucoma. METHODS: Eighteen eyes from 12 patients underwent FLIGHT, creating a single channel measuring 500-μm wide by 200-μm high through the trabecular meshwork and into Schlemm's canal. Adverse events, IOP, and other parameters were evaluated out to 24 months. MAIN OUTCOME MEASURES: Outcomes were the rates and types of adverse events and the rate of postprocedure best-corrected visual acuity loss (≥ 2 lines) compared with baseline. Efficacy outcomes were reduction in mean intraocular pressure (IOP) with respect to baseline and the percentage of eyes with a ≥ 20% reduction in IOP. RESULTS: Eighteen eyes from 12 patients were enrolled in the study; 11 patients (17 eyes) returned at 24 months. There were no serious adverse events related to the laser treatment. Well-defined channels were clearly visible at 24 months by gonioscopy and anterior segment OCT, with no evidence of closure. At 24 months, the mean IOP was reduced by 34.6% from 22.3 ± 5.5 to 14.5 ± 2.6 mmHg ( < 5e-5), with an average of 2.0 ± 1.2 hypotensive medications compared with 2.2 ± 1.1 at baseline ( = 0.22). Fourteen out of the 17 study eyes (82.3%) achieved a ≥ 20% reduction in IOP at 24 months when compared with baseline. CONCLUSION: The FLIGHT system demonstrated a favorable safety profile in this initial pilot study, with no device-related serious adverse events. The channels appeared patent at 24 months, indicating medium-term durability. FINANCIAL DISCLOSURES: Proprietary or commercial disclosure may be found after the references.
Department of Ophthalmology, Semmelweis University, Budapest, Hungary.
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