Free Papers

Safety and efficacy of automated direct selective laser trabeculoplasty: first-in-human study results

Free Paper Details

First Author: M.Goldenfeld ISRAEL

Co Author(s):    M. Belkin   M. Dobkin-Bekman   Z. Sacks   S. Blum Meirovitch   A. Leshno   A. Skaat     

Abstract Details

Purpose:

The purpose of this study was to evaluate the safety and efficacy of automated Direct Laser Trabeculoplasty (DSLT) applied without a goniolens at various energies to the peri-limbal area overlying the trabecular meshwork (TM) in lowering intra-ocular pressure (IOP) in open angle glaucoma (POAG) and ocular hypertension (OHT).

Setting:

15 eyes of 15 patients (1 eye with exfoliative glaucoma, 10 with POAG and 4 with OHT) were treated by the DSLT device in one center. 66% were males, mean age was 66.2±8.2 years. Pre-medicated patients were washed out from their glaucoma medications

Methods:

The DSLT included 100-120 sequential non-contact shots applied automatically directly on the scleral limbus using image analysis of the target and eye tracking monitoring. Laser energy between 0.8 to 1.4 mJ/shot were used. The duration of the irradiation was 1.5 seconds/100 shots.

Results:

Mean baseline IOP in patients treated with ≥1 mJ/shot was 26.8±2.5 mmHg (n=13). The IOP at 3- and 6-months post-op was significantly reduced to 20.7±2.4 and 20.8±3.8 mmHg respectively (p<0.01). In six patients treated with 1.4 mJ/shot, the 3-and 6- months follow up showed mean absolute reduction from baseline of 6.8±4.1 and 7.3±2.5 mmHg (p<0.05) respectively. There was a significant reduction in hypotensive medications from 1.6 ±1.0 to 0.4 ±0.7. Four cases of transient mild sub-conjunctival hemorrhages occurred (resolved in one day to one-week post-op without treatment). No SAE was observed.

Conclusions:

Early experience shows- an automated DSLT is a promising new modality in the treatment of POAG. Higher energy gave better sustained results. A multicenter randomized control study is being conducted to validate these results.

Financial Disclosure:

... gains financially from product or procedure presented, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... is employed by a for-profit company with an interest in the subject of the presentation, ... is employed by a competing company, ... has significant investment interest in a company producing, developing or supplying product or procedure presented