| Autor: |
Zoltan Z. Nagy, MD, PhD, Kinga Kranitz, MD, PhD, Iqbal Ike K. Ahmed, MD, Ticiana De Francesco, MD, Eric Mikula, PhD, Tibor Juhasz, PhD |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
Ophthalmology Science, Vol 3, Iss 4, Pp 100313- (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2666-9145 |
| DOI: |
10.1016/j.xops.2023.100313 |
| Popis: |
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 (P < 5e-5), with an average of 2.0 ± 1.2 hypotensive medications compared with 2.2 ± 1.1 at baseline (P = 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 Disclosure(s): Proprietary or commercial disclosure may be found after the references. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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