Primary Open Angle GlaucomaPseudoexfoliation Glaucoma
Investigational drug(s) / intervention(s)
Topical lidocaineMP-TLT
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
Relative IOP change (percent) — 6 months Relative IOP (intraocular pressure) change (percentage relative to baseline) for the entire study population. "Last observation carried forward" will be used in cases with treatment escalation or reduction during follow up. Patients with peroral glaucoma treatment at baseline are not included in this analysis.
Relative IOP change (percent) for POAG and PXFG eyes separately — 6 months Relative IOP change (percentage relative to baseline) for the eyes with a diagnosis of primary open angle glaucoma, or pseudo exfoliative glaucoma, respectively. "Last observation carried forward" will be used in cases with treatment escalation or reduction during follow up. Patients with peroral glaucoma treatment at baseline are not included in this analysis.
Perioperative pain on a visual analogue scale (VAS) — Immediately after surgery The patient will report pain during MP-TLT treatment on a VAS immediately after surgery.
A 10 cm horizontal line without markings will be presented. One end of the line represents "no pain" and the other "worst imaginable pain". The patient marks the position on the scale that corresponds to the level of perceived pain. The number of millimeters from the "no pain" end is the result. Higher is worse.
If there was a need for supplementary anesthesia, the grading applies to the experience before supplementation.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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