First-in-Human clinical study to establish the safety and efficacy of automated non-contact translimbal Direct Selective Laser Trabeculoplasty: 6-months results

Abstract

Purpose : The purpose of this study was to preliminarily determine the safety and efficacy of Direct Selective Laser Trabeculoplasty (DSLT) applied automatically without a gonioscope at various energies to the limbus overlying the trabecular meshwork in lowering intra ocular pressure (IOP) in open angle glaucoma (OAG).

Methods : Fifteen eyes of 15 patients (1 eye with exfoliative glaucoma, 4 with normal tension glaucoma and 10 with OAG) were treated by the DSLT device. The mean age was 66.2±8.2 years and 66% were males. Pre-medicated patients were washed out from their glaucoma medications for two weeks. The DSLT treatment included 100-120 sequential non-contact 532 nM, Q-switched laser shots applied automatically directly on the limbus using image analysis of the limbus location and an eye tracking system monitoring both eye and laser beam location. Before each laser was spot was applied, multiple safety checks were automatically performed. Laser energies between 0.8 to 1.4 mJ/shot were used. The total duration of the irradiation was 2.3 seconds.

Results : In the six patients who were treated with 1.0 mJ/shot, the IOP was reduced from a baseline of 26.8±2.0 mmHg by 26.6±15.1%, 18.8±11.5% & 16.2±23.5% at 1 month, 3 months & 6 months respectively.
In the six patients treated with 1.4 mJ/shot, the equivalent IOP percent reduction from a baseline of 26.7±3.2 mmHg was 20.6±11.7%, 25.6±12.9% & 26.9 ±7.1% respectively.
One case of transient reduction in visual acuity and four cases of minor sub-conjunctival hemorrhages occurred. All side effects resolved spontaneously without sequalae within one day to one week. There were no serious adverse events.

Conclusions : This early experience shows the automated non-contact rapid DSLT as a promising new modality in the treatment of POAG. Higher energy gave better-sustained results. Randomized Controlled studies with more patients are being conducted in order to validate these initial results in POAG patients

This is a 2021 ARVO Annual Meeting abstract.

 

Automated transscleral direct SLT - First in Human 6 months results