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NCT Number: NCT03798223

Optimal Treatment Protocol for Selective Laser Trabeculoplasty

A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Glaucoma, Open-Angle Exfoliation Syndrome Eye Diseases Glaucoma Iris Diseases Ocular Hypertension Pseudoexfoliation Glaucoma Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ogonkliniken, Sodra Alvsborgs Sjukhus, Borås, Västra Götaland County, Sweden

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About this study

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 ("standard" energy) or at a level that gives microbubbles at 50-75% of laser effects ("high" energy). This gives four treatment arms: 180/standard, 180/high, 360/standard 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Change in intraocular pressure (IOP)

    Time frame: Before SLT and thereafter regularly for 4 years

    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 4 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.

  2. Achievement of 20% reduction in IOP

    Time frame: For 4 years

    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.

  3. Survival (no additional intervention)

    Time frame: For 4 years

    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).

Secondary outcomes

  1. Survival (SLT allowed)

    Time frame: For 4 years

    See Outcome 3. Kaplan-Meier survival analysis is performed the same way, but additional SLT-treatment within group allocation will not be judged as failure.

  2. Pain perioperatively: on a scale

    Time frame: Immediately after treatment

    The patient will grade perioperative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol.

  3. Pain postoperatively: on a scale

    Time frame: During the first month

    The patient will grade post-operative pain on an arbitrary scale between 0 (no pain) and 4 (maximum pain) on a written protocol, also stating the duration of pain.

  4. Light sensitivity postoperatively

    Time frame: During the first month

    The patient will grade post-operative sensitivity to light on an arbitrary scale between 0 (no difference) and 4 (very intense sensitivity to light) on a written protocol, also stating the duration of light sensitivity.

  5. Impairment of vision postoperatively

    Time frame: During the first month

    The patient will grade post-operative impairment of vision on an arbitrary scale between 0 (no difference) and 4 (cannot see ones own hand) on a written protocol, also stating the duration of vision impairment.

  6. Redness postoperatively

    Time frame: During the first month

    The patient will grade post-operative redness of the eye on an arbitrary scale between 0 (no difference) and 4 (very intense redness) on a written protocol, also stating the duration of redness.

  7. Flare (inflammation measurement of the anterior chamber)

    Time frame: Pre-operatively and then one day, one week and one month post-operatively.

    15 participants from each treatment arm (60 in total, randomized in a separate block after informed consent) will undergo measurement with a Laser Flare Meter.

  8. Adverse events

    Time frame: 6 months after SLT.

    The type and frequency of adverse events will be recorded and analyzed in each of the study arms.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University

Registry information

Acronym: OSLT

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Jan 9, 2019
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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