Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial

NCT05159960 | Enrolling By Invitation

• 2 other identifiers: OSLT-R277612
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Glaucoma, Open-Angle; Pseudoexfoliation Glaucoma; Ocular Hypertension

Keywords

Selective Laser Trabeculoplasty

Outcome Measures

Primary Outcomes (1)

• Relative IOP reduction for each SLT iteration

  Relative IOP reduction for each SLT iteration is calculated as the percentage IOP reduction from baseline (the mean of 3 pre-SLT measurements) to result IOP (the mean of the IOP at follow-up 1, 3 and 6 months after SLT).

  1-6 months after each SLT, as described above

Secondary Outcomes (10)

• Survival (for each SLT iteration)

  From randomization to failure (IOP lowering intervention, except repeat SLT) or censoring (death, patients choice), assessed until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.

• Survival (repeat SLT allowed)

  From each SLT iteration to failure (IOP lowering intervention incl. repeat SLT) or censoring (death, patients choice), assessed until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.

• Achievement of 20% reduction in IOP

  From randomization until the last of: 1. 3 years after randomization; 2. 31 Dec 2024 or; 3. Six months after the last SLT during that timespan.

• Absolute IOP reduction for each SLT iteration

  1-6 months after each SLT, as described above

• Pain perioperatively: on a scale

  Immediately after treatment

Study Arms (4)

180/low

EXPERIMENTAL

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.

Procedure: SLT

180/high

EXPERIMENTAL

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.

Procedure: SLT

360/low

EXPERIMENTAL

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.

Procedure: SLT

360/high

EXPERIMENTAL

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.

Procedure: SLT

Interventions

SLT 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; 180/low; 360/high; 360/low

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (2)

Department of Ophthalmology, Skaraborg Hospital

Skövde, Västra Götaland County, 54142, Sweden

Location

Department of Ophthalmology, NU Hospital Group

Uddevalla, Västra Götaland County, 45153, Sweden

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Exfoliation Syndrome; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases; Iris Diseases; Uveal Diseases

Study Officials

• Tobias Dahlgren, MD

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

• Marcelo Ayala, MD, PhD

  Vastra Gotaland Region

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The treatment protocol is masked for the patient and for the nurses and optometrists conducting measurement of intraocular pressure during follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 16, 2021
• Study Start: January 10, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)