Micropulse diode laser trabeculoplasty (MDLT): a phase II clinical study with 12 months follow up

Abstract OBJECTIVE: This pilot study evaluates the pressure lowering potential of subthreshold micropulse diode laser trabeculoplasty (MDLT) for a clinically meaningful duration in patients with medically uncontrolled open angle glaucoma (OAG). DESIGN: prospective interventional case series. PARTICIPANTS: Thirty-two eyes of 20 consecutive patients with uncontrolled OAG (12 bilateral and 8 unilateral). METHODS: Confluent subthreshold laser applications over the inferior 180 degrees of the anterior TM using an 810 nm diode laser in a micropulse operating mode. The intraocular pressure (IOP) was measured at baseline and at 1 hour, 1 day, 1 week, 3, 6, 9, and 12 months post-treatment. Flare was measured with a Kowa FM 500 flare-meter at baseline and at 3 hours, 1 day, 1 week, and 12 months post-treatment. After treatment, the patients were maintained on their pre-treatment drug regimen. MAIN OUTCOME MEASURES: Criteria for treatment response were IOP reduction >/=3 mm Hg and IOP </=21 mm Hg within the first week after MDLT. Eyes not complying to the above criteria during the follow-up were considered treatment failure. Mean IOP change and percentage of IOP reduction during the follow-up were calculated. RESULTS: One eye was analyzed for bilateral patients. A total of 20 eyes were thus included. Four eyes (20%) did not respond to treatment during the first week. One additional eye failed at the 6 month visit. The treatment was successful in 15 eyes (75%) at 12 months. The IOP was significantly lower throughout follow-up (p < 0.01). At 12 months, the mean percentage of IOP reduction in the 15 respondent eyes was 22.1% and 12 eyes (60%) had IOP reduction higher than 20%. During the first two postoperative days, one eye with pigmentary glaucoma experienced a significant increase of flare associated with an IOP spike (34 mm Hg) that was controlled with systemic drugs; afterwards it qualified as a respondent and completed the study. No increase of flare was found in any other patient. No peripheral anterior synechiae formed. CONCLUSIONS: In this case series, MDLT was effective in reducing IOP in 75% of medically insufficiently controlled OAG eyes without significant complications. This justifies randomized clinical studies to compare MDLT with current IOP lowering strategies.