Optimal Treatment Protocol for Selective Laser Trabeculoplasty

NCT ID: NCT03798223

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2027-12-31

Brief 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

Study Design

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

Study Groups

180/low

SLT treatment in the lower 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 the lower 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

• 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.

• 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

Marcelo Ayala, MD, PhD

Role: STUDY_CHAIR

Vastra Gotaland Region

Tobias Dahlgren, MD

Role: PRINCIPAL_INVESTIGATOR

Vastra Gotaland Region

Locations

Ogonkliniken, Sodra Alvsborgs Sjukhus

Borås, Västra Götaland County, Sweden

Ogonkliniken, Sahlgrenska Universitetssjukhuset

Mölndal, Västra Götaland County, Sweden

Ogonkliniken, Skaraborgs Sjukhus

Skövde, Västra Götaland County, Sweden

Ogonkliniken NU-sjukvarden

Uddevalla, Västra Götaland County, Sweden

Countries

Sweden

Other Identifiers

254861

Identifier Type: OTHER

Identifier Source: secondary_id

Optimal SLT

Identifier Type: -

Identifier Source: org_study_id