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ENROLLING BY INVITATION
NCT05557721

Uddevalla Skövde Transscleral Micropulse Study

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2023-10-06

Completion Date

2025-12-31

Last Updated

2024-12-03

Healthy Volunteers

No

Interventions

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.

Locations (2)

Department of Ophthalmology, Skaraborg Hospital

Skövde, Västra Götaland County, Sweden

Department of Ophthalmology, NU Hospital Group

Uddevalla, Västra Götaland County, Sweden