NCT05557721Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 19 Sept 2022
- Start date
- 6 Oct 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Glaucoma
- NCT number
- NCT05557721
What you commit to
- Study type: Observational
- Planned participants: 40
- From 6 Oct 2023 to the primary completion date, 31 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior transscleral laser or cryo treatment.
- Planned or expected eye surgery (eg., cataract surgery or intravitreal injection) in the coming year.
Other illness
- Allergy or hypersensitivity to tetracaine or lidocaine
- History of macular edema.
- History of corneal edema.
- History of uveitis during the past year.
Lab values
- Prior eye surgery (including intravitreal injection) or pressure-lowering laser treatment (SLT/ALT/MDLT) during the last 2 months.
Other
- Existing thinning in the sclera of a greater extent than 30 degrees (one "clock-hour") of the circumference.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Ophthalmology, Skaraborg Hospital Coordinator of this site? Confirm its status | Skövde | Sweden | Unknown status |
| Department of Ophthalmology, NU Hospital Group Coordinator of this site? Confirm its status | Uddevalla | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.