New non-penetrating laser procedure reduced IOP, glaucoma medication use in study
RAMAT GAN, Israel A non-invasive, laser-based surgical method reduced IOP and eliminated the need for glaucoma medication in more than 86% of patients, according to early clinical trial results.
The new procedure may reduce IOP without the risks and side effects of trabeculectomy and non-penetrating deep sclerectomy, IOPtima, the laser's manufacturer, said in a press release.
Six-month study data showed that among 30 patients who underwent the procedure, average IOP was reduced from 26 mm Hg preop to 14 mm Hg postop. The study was deemed a complete success, with IOP being reduced to less than 18 mm Hg and the elimination of the need for glaucoma medication, in 86.7% of patients.
The laser procedure poses less risk of perforating the thin trabecular membrane than non-penetrating deep sclerectomy because the carbon dioxide laser ceases ablation when optimal thickness of the membrane is reached.
"Our non-penetrating technology and procedure is very easy to perform, unlike other non-penetrating methods which, because of their difficulty, can only be implemented by a small number of highly trained surgeons," Dr. Joshua Degani, CEO of IOPtima, said in the release.
Investigators plan to collect study data for up to 1 year after surgery. The multinational clinical trial is intended to gain regulatory approval in Europe. IOPtima has also begun discussing approval with the U.S. Food and Drug Administration, the release said.