Sustained 36-Month Reduction In Intraocular Pressure In Open-Angle Glaucoma With Femtosecond Laser-Guided High-Precision Trabeculotomy (Flight)

To evaluate channel patency, intraocular pressure (IOP) reduction, and safety over a 36-month period in the initial cohort of patients treated with a non-invasive glaucoma procedure termed, Femtosecond Laser image-guided High-Precision Trabeculotomy (FLigHT).

The procedure took place at a single investigational center located in Budapest, Hungary.  The FLigHT procedure utilizes real time, high definition gonioscopic imaging for precise positioning of the femtosecond trabeculotomy within the trabecular meshwork.  The device allows for the creation of the trabeculotomy within 300 degrees of the iridocorneal angle, facilitating temporal intervention as appropriate.

Between September and October 2020, 18 eyes of 12 patients diagnosed with mild to advanced open-angle glaucoma received a single 200 μm (H) x 500 μm (W) x 400 μm (D) non-incisional trabeculotomy performed in the nasal quadrant.  These eyes had not undergone prior glaucoma treatment, with the exception of hypotensive medications.  The ViaLase system (ViaLase, Aliso Viejo, CA) administered 400 femtosecond pulses at a wavelength of 1030 nm. Pre- and post-operative assessments included intraocular pressure (IOP) measured with the Goldmann tonometer, glaucoma medication status, ocular health examination, gonioscopy, visual field testing, best-corrected visual acuity (BCVA), and adverse event (AE) monitoring. Follow-up continued for 36 months.

Mean age of patients at enrollment was 72.2 ± 9.7 years. Among the participants, 92% were female, all Caucasian and 89% pseudophakic. Glaucoma severity was distributed as follows: 33% mild, 28% moderate, and 39% severe. Mean preoperative IOP was 21.4 ± 4.6 mmHg with an average of 2.1 ± 1.0 classes of glaucoma medications. 13/18 eyes completed the 36-month follow-up. Gonioscopic examination revealed that 100% of the trabeculotomies were patent with no peripheral anterior synechiae (PAS). At 36 months, mean IOP was 15.2 ± 2.5 mmHg (p < 0.001 vs. baseline, two-sided t-test), and mean number of medications was 1.7 ± 1.3 (p = 0.30). No incisional glaucoma surgeries were performed,  two eyes underwent cataract surgery at 27 and 35 months.

The 36-month follow-up in this initial human study involving 18 eyes indicates that the FLigHT procedure may sustain a reduction in intraocular pressure (IOP) for up to 36 months. The treated channels remained open and exhibited no signs of chronic inflammatory response such as peripheral anterior synechiae (PAS). Further assessment is necessary to determine the efficacy of this procedure as both a primary and secondary treatment option for open-angle glaucoma (OAG).