Patient enrollment in a multicenter trial to study trabeculoplasty performed with a titanium-sapphire laser (SOLX 790, OccuLogix) is complete, according to the laser's manufacturer.
Boston-Patient enrollment in a multicenter trial to study trabeculoplasty performed with a titanium-sapphire laser (SOLX 790, OccuLogix) is complete, according to the laser's manufacturer. The research is being conducted in more than 160 eyes in an effort to obtain 510(k) clearance from the FDA.
Enrollees are patients with primary open-angle glaucoma in eyes with poorly controlled IOP on maximally tolerated medications or prior failed glaucoma surgery. Patients were randomly assigned to undergo outpatient treatment with the titanium-sapphire laser or with an argon laser. Each group contains a similar number of eyes, and each of the investigational sites-in the United States, Canada, Israel, and Spain-has a similar number of eyes enrolled. Preliminary review of the data shows consistent, equivalent IOP reduction in patients in both groups followed for up to 1 year, according to the company.
"This laser is the first of its kind to use the 790-nm wavelength, which has been shown to penetrate the tissue deeper than other laser trabeculoplasty procedures while preserving the integrity of the trabecular meshwork," said Doug Adams, chief executive officer and founder of SOLX, the glaucoma division of OccuLogix.