NCT03798223

Optimal Treatment Protocol for Selective Laser Trabeculoplasty

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.

Detailed description

A randomized controlled trial in which individuals scheduled for SLT are randomized to one of four treatment protocols, which represent the most common variants of the treatment in clinical use. Treatment is performed either at 360 degrees or 180 degrees and with a laser energy level either 0,1 millijoules (mJ) below the microbubble formation limit ("low" energy) or at a level that gives microbubbles at 50-75% of laser effects ("high" energy). This gives four treatment arms: 180/low, 180/high, 360/low and 360/high. Group allocation is masked for the patient and is coded in the records. The results for short and long term treatment effects are compared between the groups, as well as the complication rate and postoperative discomfort.

Conditions

• Glaucoma, Open-Angle
• Pseudoexfoliation Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
PROCEDURE	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).

Timeline

• Start date: 2019-01-10
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2019-01-09
• Last updated: 2025-10-03

Locations

4 sites across 1 country: Sweden