NCT05159960

Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial

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

Summary

Glaucoma is a common eye disease that can lead to blindness. The only known way to reduce the rate of disease progression is by reducing the pressure in the eye (the intraocular pressure, IOP). Selective laser trabeculoplasty (SLT) is an ophthalmic laser intervention with the purpose of reducing the IOP. SLT can be performed in different ways, with four of the treatment protocols being evaluated in the Optimal SLT (OSLT) trial. SLT is a repeatable procedure, but scientific evidence is scarce regarding more than one repetition. In this trial, patients included in the OSLT trial will be invited to the extended trial (OSLT-R), for further follow-up and re-treatment with SLT, if needed.

Detailed description

Subjects already included in the OSLT trial (NCT03798223) will be invited to the extended trial (OSLT-R) at the time of SLT re-treatment or when OSLT follow up is scheduled to terminate. Patients are re-treated as needed, according to the randomized group assignment performed in the OSLT inclusion process. The OSLT-R trial is aiming to elucidate: * If the SLT efficacy, in terms of relative IOP reduction (percent of baseline IOP), changes with additional SLT iterations. * If the longevity of IOP reduction after SLT changes with additional SLT iterations. * If repeated SLT is associated with a change in postoperative discomfort or adverse events. All of the above will be analyzed within each of the four treatment groups (SLT protocols) in the trial. Further, analysis will also be conducted regarding differences between the treatment groups regarding the above. Further, analysis will be performed regarding SLT efficacy depending of the total number of SLT:s an eye has received, including those performed before entering the OSLT and OSLT-R trials.

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: 2022-01-10
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-12-16
• Last updated: 2025-09-30

Locations

2 sites across 1 country: Sweden