Safety and efficacy of MicroPulse transscleral laser therapy with the revised P3 delivery device: A randomized controlled trial

ObjectiveTo evaluate the safety and efficacy of MicroPulse Transscleral Laser Therapy (MicroPulse TLT) with the Revised P3^® Delivery Device.DesignProspective, single-surgeon, interventional study in a tertiary hospital setting.ParticipantsSixty-two eyes of 40 patients with refractory glaucoma.MethodsAll subjects received 360-degree MicroPulse TLT treatment (2500 mW, 31.33% duty cycle) over a total of 240 s (8 sweeps; <i>n</i> = 20), 300 s (10 sweeps; <i>n</i> = 22), or 200 s (10 sweeps; <i>n</i> = 20). Participants were followed up for 6 months to assess changes in intraocular pressure (IOP), glaucoma medication burden, and best-corrected visual acuity (BCVA). Surgical success was defined as a reduction of IOP ≥ 30% from baseline and between 6-18 mmHg at last follow-up with no additional anti-glaucoma medications or secondary reinterventions.ResultsSurgical success was achieved in 72.7% (300 s group), 75.0% (240 s group), and 80.0% (200 s group) of eyes. Mean IOP was significantly reduced (<i>p</i> < 0.001) by 49.0% (300 s group), 45.66% (240 s group), and 39.8% (200 s group) at 6 months. With all groups combined, the mean number of glaucoma medications was significantly reduced by 17.8% (<i>p</i> = 0.005), and no significant changes in BCVA were observed at 6 months. Complications were minimal, including four eyes with IOP spikes, one eye with hyphema, and one eye with cystoid macular edema (CME), all of which resolved. Two eyes of the total sample (3.2%) required secondary glaucoma surgery before 6 months.ConclusionsSecond-generation MicroPulse TLT at fluence values of 154-229 J/cm² appears to be a safe and effective option for IOP reduction in refractory glaucoma.