Título
24-month Outcomes
Autores
Zoltan Z. Nagy, MD, PhD¹; Kinga Kranitz, MD, PhD¹; Iqbal Ike K. Ahmed, MD²˒³; Ticiana De Francesco, MD²˒⁴; Eric Mikula, PhD⁵˒⁶; Tibor Juhasz, PhD⁵˒⁶˒⁷.
Purpose
To evaluate the adverse events and intraocular pressure (IOP)-lowering efficacy 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 the FLIGHT procedure, which created a single channel measuring 500 μm in width by 200 μm in height through the trabecular meshwork and into Schlemm’s canal.
Adverse events, IOP, and other clinical parameters were evaluated for up to 24 months following the procedure.
Main Outcome Measures
The primary safety outcomes were the rates and types of adverse events and the rate of postprocedure loss of best-corrected visual acuity of 2 or more lines compared with baseline.
The efficacy outcomes included the reduction in mean IOP compared with baseline and the proportion of eyes achieving at least a 20% reduction in IOP.
Results
Eighteen eyes from 12 patients were enrolled in the study, and 11 patients, corresponding to 17 eyes, completed the 24-month follow-up.
No serious adverse events related to the laser treatment were reported. Well-defined channels remained clearly visible at 24 months on gonioscopy and anterior segment optical coherence tomography, with no evidence of channel closure.
At 24 months, the mean IOP was reduced by 34.6%, decreasing from 22.3 ± 5.5 mmHg at baseline to 14.5 ± 2.6 mmHg (P < 5 × 10⁻⁵).
The average number of hypotensive medications was 2.0 ± 1.2 at 24 months compared with 2.2 ± 1.1 at baseline, with no statistically significant difference between the two time points (P = 0.22).
Fourteen of the 17 study eyes (82.3%) achieved a reduction of at least 20% in IOP at 24 months 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 created by the procedure remained patent at 24 months, indicating medium-term durability. The observed reduction in IOP and the high proportion of eyes achieving at least a 20% IOP reduction suggest potential efficacy of this novel, noninvasive approach for the treatment of open-angle glaucoma.
Financial Disclosure
Proprietary or commercial disclosures may be found after the references in the original publication.
Referência
Ophthalmology Science. 2023;3:100313. © 2023 by the American Academy of Ophthalmology.
This is an open-access article distributed under the CC BY-NC-ND license.
Supplemental material is available at Ophthalmology Science.