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NCT05557721 | Enrolling by invitation | Primary Open Angle Glaucoma


Uddevalla Skövde Transscleral Micropulse Study
Sponsor:

Vastra Gotaland Region

Brief 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.

Condition or disease

Primary Open Angle Glaucoma

Pseudoexfoliation Glaucoma

Intervention/treatment

Topical lidocaine

MP-TLT

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.

Study Type : Observational
Estimated Enrollment : 40 participants
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
Actual Study Start Date : October 6, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.

Uddevalla Skövde Transscleral Micropulse Study

Location Details


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Uddevalla Skövde Transscleral Micropulse Study

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Sweden, Vastra Gotaland

Department of Ophthalmology, Skaraborg Hospital

Skövde, Vastra Gotaland, Sweden, 54142

Not yet recruiting

Sweden, Vastra Gotaland

Department of Ophthalmology, NU Hospital Group

Uddevalla, Vastra Gotaland, Sweden, 45153

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