Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial

NCT ID: NCT05159960

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

180/low

SLT treatment in either half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.

Group Type: EXPERIMENTAL

SLT

Intervention Type: PROCEDURE

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).

180/high

SLT treatment in either half of the trabecular meshwork (180 degrees) consisting of 50+/-5 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.

Group Type: EXPERIMENTAL

SLT

Intervention Type: PROCEDURE

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).

360/low

SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted 0,1 mJ below the threshold of formation of micro bubbles.

Group Type: EXPERIMENTAL

SLT

Intervention Type: PROCEDURE

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).

360/high

SLT treatment in the full circumference of the trabecular meshwork (360 degrees) consisting of 100+/-10 adjacent laser effects. The energy is adjusted to achieve the formation of micro bubbles at 50-75% of laser effects.

Group Type: EXPERIMENTAL

SLT

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Included in the OSLT trial
• Followed up without the need for other treatment escalation than repeat SLT

Exclusion Criteria

• Unable to participate in follow up due to health conditions, strength or physical location.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Dahlgren, MD

Role: PRINCIPAL_INVESTIGATOR

Vastra Gotaland Region

Marcelo Ayala, MD, PhD

Role: STUDY_CHAIR

Vastra Gotaland Region

Locations

Department of Ophthalmology, Skaraborg Hospital

Skövde, Västra Götaland County, Sweden

Department of Ophthalmology, NU Hospital Group

Uddevalla, Västra Götaland County, Sweden

Countries

Sweden

Other Identifiers

277612

Identifier Type: OTHER

Identifier Source: secondary_id

OSLT-R

Identifier Type: -

Identifier Source: org_study_id