Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
40 participants
OBSERVATIONAL
2023-10-06
2025-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MP-TLT in topical anesthesia
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.
Topical lidocaine
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.
MP-TLT
Micro pulse transscleral laser treatment 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.
Interventions
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Topical lidocaine
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.
MP-TLT
Micro pulse transscleral laser treatment 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Göteborg University
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Tobias Dahlgren, MD
Role: PRINCIPAL_INVESTIGATOR
Vastra Gotaland Region
Marcelo Ayala, MD, PhD
Role: STUDY_CHAIR
Vastra Gotaland Region
Locations
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Department of Ophthalmology, Skaraborg Hospital
Skövde, Västra Götaland County, Sweden
Department of Ophthalmology, NU Hospital Group
Uddevalla, Västra Götaland County, Sweden
Countries
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References
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Grippo TM, de Crom RMPC, Giovingo M, Toteberg-Harms M, Francis BA, Jerkins B, Brubaker JW, Radcliffe N, An J, Noecker R. Evidence-Based Consensus Guidelines Series for MicroPulse Transscleral Laser Therapy: Dosimetry and Patient Selection. Clin Ophthalmol. 2022 Jun 7;16:1837-1846. doi: 10.2147/OPTH.S365647. eCollection 2022.
Other Identifiers
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278487
Identifier Type: REGISTRY
Identifier Source: secondary_id
USTMS
Identifier Type: -
Identifier Source: org_study_id