NCT05557721

Uddevalla Skövde Transscleral Micropulse Study

Uddevalla Skövde Transscleral Micropulse Study: Efficacy and Safety of Micro Pulse Transscleral Laser Treatment (MP-TLT) in Glaucoma Patients Performed in Topical Lidocaine Anaesthesia

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Micro pulse transscleral laser treatment (MP-TLT) is a relatively new method to reduce the intraocular pressure (IOP) in glaucoma. New recommendations regarding the treatment protocol has recently been developed and was published 2022. The overall objective is to evaluate the efficacy and safety of the proposed treatment method in an independent study. In addition, the outcome of MP-TLT in patients with pseudoexfoliation glaucoma, which is relatively common in the Nordic countries, and primary open angle glaucoma will be studied separately. The IOP change over the course of one year will be monitored, as well as success rate and survival. Further, patient-reported discomfort from the treatment and the occurrence of any adverse events or complications will be studied.

Detailed description

Forty patients scheduled for MP-TLT by their ophthalmologist will be recruited. One eye per patient is included, based on randomization, even if both are treated. MP-TLT will be performed according to the current recommendations. Baseline IOP will be calculated as the mean of three separate measurements taken on different days preoperatively. IOP will then be measured 1 week, 1 month, 3 months, 6 months and 12 months after MP-TLT. The central corneal thickness (CCT), the central retinal thickness (CRT), anterior chamber flare and the visual field (HFA 24-2 faster) will also be measured preoperatively and during follow up. In accordance with the World Glaucoma Association guidelines, no adjustment for multiple comparisons is planned in this study.

Conditions

• Primary Open Angle Glaucoma
• Pseudoexfoliation Glaucoma

Interventions

Type	Name	Description
PROCEDURE	Topical lidocaine	Patients will receive topical anesthesia with tetracaine hydrochloride 1% three times, 5 minutes apart. Then, lidocaine gel 2% will be applied on the surface of the eye and refilled as needed for 10 minutes, as well as manipulated for a good coverage.
PROCEDURE	MP-TLT	Micro pulse transscleral laser treatment will be performed with the Iridex CycloG6 laser with the revised P3 probe, according to the recent consensus recommendations. In brief, this includes MP-TLT with 2500 mW, 31.3% duty cycle, four 20 second sweeps per hemisphere, avoiding the 3 and 9 o'clock meridians and sectors with scleral thinning.

Timeline

• Start date: 2023-10-06
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-09-28
• Last updated: 2024-12-03

Locations

2 sites across 1 country: Sweden