By InvitationNot Applicable

Uddevalla Skövde Transscleral Micropulse Study

Sweden40 participantsStarted 2023-10-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of primary open angle glaucoma (POAG) or pseudo exfoliative glaucoma (PXFG) * Age ≥ 18 years * The patient is expected to be able to adequately undergo and cooperate in the treatment and follow-up as described in the study protocol. * The patient is judged to have good compliance with already prescribed pharmacological glaucoma treatment. Exclusion Criteria: * Allergy or hypersensitivity to tetracaine or lidocaine * Prior transscleral laser or cryo treatment. * Prior eye surgery (including intravitreal injection) or pressure-lowering laser treatment (SLT/ALT/MDLT) during the last 2 months. * Planned or expected eye surgery (eg., cataract surgery or intravitreal injection) in the coming year. * History of macular edema. * History of corneal edema. * History of uveitis during the past year. * Existing thinning in the sclera of a greater extent than 30 degrees (one "clock-hour") of the circumference.

What they're measuring

Relative IOP change (percent)

Timeframe: 6 months

Relative IOP change (percent) for POAG and PXFG eyes separately

Timeframe: 6 months

Perioperative pain on a visual analogue scale (VAS)

Timeframe: Immediately after surgery

Trial details

NCT IDNCT05557721

SponsorVastra Gotaland Region

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-12-31