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

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.

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.

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.