Uddevalla Skövde Transscleral Micropulse Study (USTMS)

Vastra Gotaland Region

Status: Invitation-only

Conditions: Primary Open Angle Glaucoma; Pseudoexfoliation Glaucoma

Treatments: Procedure: Topical lidocaine; Procedure: MP-TLT

Study type: Observational

Funder types: Other

Identifiers

NCT05557721

USTMS

278487 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

MP-TLT in topical anesthesia

Description:

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. Thereafter, MP-TLT 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.

Treatment:

Procedure: MP-TLT

Procedure: Topical lidocaine