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Enrolling by Invitation

NCT Number: NCT05159960

Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial

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.

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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

Department of Ophthalmology, Skaraborg Hospital, Skövde, Västra Götaland County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

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. Relative IOP reduction for each SLT iteration

    Time frame: 1-6 months after each SLT, as described above

    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).

Secondary outcomes

  1. Survival (for each SLT iteration)

    Time frame: 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.

    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, including repeat SLT.

  2. Survival (repeat SLT allowed)

    Time frame: 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.

    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, except repeat SLT.

  3. Achievement of 20% reduction in IOP

    Time frame: 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.

    The proportion of eyes achieving and maintaining an IOP reduction of at least 20% compared to baseline.

  4. Absolute IOP reduction for each SLT iteration

    Time frame: 1-6 months after each SLT, as described above

    Absolute IOP reduction for each SLT iteration is calculated as the IOP reduction, in mmHg, 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).

  5. 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.

  6. 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.

  7. Light sensitivity postoperatively: on a scale

    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.

  8. Impairment of vision postoperatively: on a scale

    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.

  9. Redness postoperatively: on a scale

    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.

  10. Adverse events

    Time frame: 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. However, generally adverse events are anticipated to emerge in the first post-operative days or weeks.

    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-R

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2021
Registry last updated
Sep 30, 2025

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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