First-in-Human Safety Study of Femtosecond Laser Image-Guided Trabeculotomy for Glaucoma Treatment: 24-month Outcomes

Zoltan Z Nagy; Kinga Kranitz; Iqbal Ike K Ahmed; Ticiana De Francesco; Eric Mikula; Tibor Juhasz

doi:10.1016/j.xops.2023.100313

First-in-Human Safety Study of Femtosecond Laser Image-Guided Trabeculotomy for Glaucoma Treatment: 24-month Outcomes

Ophthalmol Sci. 2023 Apr 17;3(4):100313. doi: 10.1016/j.xops.2023.100313. eCollection 2023 Dec.

Authors

Zoltan Z Nagy¹, Kinga Kranitz¹, Iqbal Ike K Ahmed^{2

3}, Ticiana De Francesco^{2

4}, Eric Mikula^{5

6}, Tibor Juhasz^{5

6

7}

Affiliations

¹ Department of Ophthalmology, Semmelweis University, Budapest, Hungary.
² John Moran Eye Center, University of Utah, Salt Lake City, Utah.
³ Department of Ophthalmology & Vision Sciences, University of Toronto, Toronto, Ontario, Canada.
⁴ Clinica de Olhos De Francesco, Fortaleza, Brazil & Hospital de Olhos Leiria de Andrade (HOLA), Fortaleza, Brazil.
⁵ ViaLase Inc., Aliso Viejo, California.
⁶ Department of Ophthalmology, University of California, Irvine, Irvine, Califorania.
⁷ Department of Biomedical Engineering, University of California, Irvine, Irvine, California.

Abstract

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 disclosures: Proprietary or commercial disclosure may be found after the references.

Keywords: Femtosecond laser trabeculotomy; Glaucoma treatment; Laser therapy; Microinvasive glaucoma surgery.