Clinical trial NCT05557721: Uddevalla Skövde Transscleral Micropulse Study
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Primary Open Angle Glaucoma
Pseudoexfoliation Glaucoma
Keywords: Micro pulse transscleral laser treatment (MP-TLT)
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
First posted: 2022-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 patients referred for MP-TLT at the ophthalmology departments of the NU Hospital Group and the Skaraborg Hospital are recruited sequentially.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Relative IOP change (percent)
timeFrame: 6 months
measure: Relative IOP change (percent) for POAG and PXFG eyes separately
timeFrame: 6 months
measure: Perioperative pain on a visual analogue scale (VAS)
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Success proportion after 12 months
timeFrame: 12 months
measure: Survival
timeFrame: 12 months
measure: Relative change (percent) of the IOP 1 week, 1 month, 3 months and 12 months after MP-TLT.
timeFrame: 12 months
measure: Postoperative pain on a VAS 1 hour, 5 hours, and 24 hours postoperatively
timeFrame: 1 hour, 5 hours, and 24 hours postoperatively
measure: Patient reported discomfort on an arbitrary scale
timeFrame: 1 month
measure: Change in central retinal thickness (CRT) postoperatively
timeFrame: 3 months
measure: Change in central corneal thickness (CCT) postoperatively
timeFrame: 1 month
measure: Change of flare in the anterior chamber postoperatively
timeFrame: 1 month
measure: Change in visual field index (VFI) during follow-up
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Skövde
country: Sweden
facility: Department of Ophthalmology, Skaraborg Hospital
state: Vastra Gotaland
city: Uddevalla
country: Sweden
facility: Department of Ophthalmology, NU Hospital Group
state: Vastra Gotaland
Study officials:
affiliation: Vastra Gotaland Region
name: Tobias Dahlgren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vastra Gotaland Region
name: Marcelo Ayala, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.