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Completed
NCT07756411
Selective, Micropulse and Pattern Laser Trabeculoplasty in Medically Treated Open-angle Glaucoma.
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: University of Udine
Location: Glaucoma Unit, Department of Medicine - Ophthalmology, University of Udine Udine UD
Summary
This randomized, single-centre, three-arm trial compared three subvisible laser trabeculoplasty delivery protocols in eyes with open-angle glaucoma already receiving intraocular pressure (IOP)-lowering medication: selective laser trabeculoplasty (SLT, 3-nanosecond pulses), micropulse laser trabeculoplasty (MLT, 577 nm with 15% duty cycle), and pattern laser trabeculoplasty (PLT, 5-ms pattern delivery). Ninety eyes of 90 patients were allocated 1:1:1 to a single 360-degree session and followed for 6 months. The primary outcome was IOP at 6 months, with an equivalence margin of +/-2.0 mmHg prespecified for pairwise comparisons. Secondary outcomes were percentage IOP change, number of IOP-lowering medications, cumulative treatment success (IOP reduction of at least 20% from baseline without an increase in medications), and adverse events. Outcome assessment was performed by a second ophthalmologist masked to allocation and to clinical history.
Eligibility Criteria
Inclusion Criteria:
* adults with primary or secondary open-angle glaucoma.
* gonioscopically open angle confirmed by gonioscopy in the study eye.
* receiving intraocular pressure-lowering medication at entry, with an indication for subvisible laser trabeculoplasty according to standard practice at the unit (IOP inadequately controlled on medical therapy, intolerance of medical therapy, or both).
* written informed consent.
Exclusion Criteria:
* previous laser trabeculoplasty, iridotomy or iridoplasty.
* corneal disease precluding visualization of the trabecular meshwork or reliable applanation tonometry.
* previous intraocular surgery other than uncomplicated cataract extraction.
* systemic medication known to affect intraocular pressure.
* pregnancy.
Source: ClinicalTrials.gov (NCT07756411). StuddyBuddy aggregates publicly available trial information.