SLT: A drop of Pilocarpine 4% is administered to the eye 20 minutes before SLT. Immediately before SLT a drop of Tetracaine hydrochloride 1% is administered. Selective laser trabeculoplasty is conducted through a Latina lens, in a fashion determined by randomization to a study arm (see description).
Study summary
A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* diagnosis primary open-angle glaucoma, pseudo-exfoliative glaucoma or ocular hypertension.
* intra-ocular pressure (IOP) at least 18 mmHg treatment day.
* treatment is performed by an experienced laser surgeon.
* SLT treatment and follow-up are expected to be possible to perform in an adequate way, considering anatomical factors, age and the general health of the patient.
Exclusion Criteria:
* change of IOP-lowering medication during the last three months.
* planned change of intra-ocular-pressure-lowering medication.
* previous glaucoma surgery (other than SLT and ALT)
* previous intra-ocular surgery during the last three months.
* previous intra-ocular inflammatory disease during the last year.
* planned intra-ocular surgery.
* hyper-pigmented anterior chamber angle.
Primary outcome measure(s)
Change in intraocular pressure (IOP) — Before SLT and thereafter regularly for 4 years The IOP is measured with a Goldmann Applanation Tonometer (GAT) three times before SLT and then at regular intervals after the procedure. The reduction is registered and analyzed in absolute (mmHg) and relative (percent of the IOP before SLT) measures.
Measurement of IOP is planned 1, 3, 6 and 12 months post SLT, and thereafter every six months for 4 years after SLT. The study is conducted in a regular clinical setting and the above mentioned times might be delayed. If target pressure is not achieved, measurements will be planned at shorter intervals, according to a specified algorithm, due to safety reasons.
Achievement of 20% reduction in IOP — For 4 years See Outcome 1. Analysis of differences between the study arms will also be conducted measuring the proportion of eyes achieving 20% reduction in IOP or more at different time points in each group.
Survival (no additional intervention) — For 4 years Kaplan-Meier survival analysis will be conducted, measuring the proportion of eyes that stay in the study groups but do not receive any further IOP-lowering intervention (medical, surgical or laser).
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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