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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Department of Ophthalmology, Skaraborg Hospital
Skövde, Västra Götaland County, Sweden
Department of Ophthalmology, NU Hospital Group
Uddevalla, Västra Götaland County, Sweden
Start Date
October 6, 2023
Primary Completion Date
December 31, 2025
Completion Date
December 31, 2025
Last Updated
December 3, 2024
40
ESTIMATED participants
Topical lidocaine
PROCEDURE
MP-TLT
PROCEDURE
Lead Sponsor
Vastra Gotaland Region
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06865144