Optimal Treatment Protocol for Selective Laser Trabeculoplasty

NCT03798223 | Active Not Recruiting

• 2 other identifiers: Optimal SLT254861
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

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.

Conditions

Glaucoma, Open-Angle; Pseudoexfoliation Glaucoma; Ocular Hypertension

Keywords

Selective Laser Trabeculoplasty

Outcome Measures

Primary Outcomes (3)

• Change in intraocular pressure (IOP)

  The IOP is measured with a Goldmann Applanation Tonometer (GAT) three times before SLT and then at regular intervals after the procedure. The reduction is registered and analyzed in absolute (mmHg) and relative (percent of the IOP before SLT) measures. Measurement of IOP is planned 1, 3, 6 and 12 months post SLT, and thereafter every six months for 3 years after SLT. The study is conducted in a regular clinical setting and the above mentioned times might be delayed. If target pressure is not achieved, measurements will be planned at shorter intervals, according to a specified algorithm, due to safety reasons.

  Before SLT and thereafter regularly for 3 years

• Achievement of 20% reduction in IOP

  See Outcome 1. Analysis of differences between the study arms will also be conducted measuring the proportion of eyes achieving 20% reduction in IOP or more at different time points in each group.

  For 3 years

• Survival (no additional intervention)

  Kaplan-Meier survival analysis will be conducted, measuring the proportion of eyes that stay in the study groups but do not receive any further IOP-lowering intervention (medical, surgical or laser).

  For 3 years

Secondary Outcomes (8)

• Survival (SLT allowed)

  For 3 years

• Pain perioperatively: on a scale

  Immediately after treatment

• Pain postoperatively: on a scale

  During the first month

• Light sensitivity postoperatively

  During the first month

• Impairment of vision postoperatively

  During the first month

Study Arms (4)

180/low

EXPERIMENTAL

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.

Procedure: SLT

180/high

EXPERIMENTAL

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.

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (4)

Ogonkliniken, Sodra Alvsborgs Sjukhus

Borås, Västra Götaland County, 50182, Sweden

Location

Ogonkliniken, Sahlgrenska Universitetssjukhuset

Mölndal, Västra Götaland County, 43130, Sweden

Location

Ogonkliniken, Skaraborgs Sjukhus

Skövde, Västra Götaland County, 54142, Sweden

Location

Ogonkliniken NU-sjukvarden

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

• Marcelo Ayala, MD, PhD

  Vastra Gotaland Region

  STUDY CHAIR

• Tobias Dahlgren, MD

  Vastra Gotaland Region

  PRINCIPAL INVESTIGATOR

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 conducting measures of intraocular pressure during follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 9, 2019
• Study Start: January 10, 2019
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)