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Glaucoma, Open-AngleOSLT-RNCT05159960

Optimal Treatment Protocol for Selective Laser Trabeculoplasty - Repeat Trial

A study testing SLT in people with Glaucoma, Open-Angle and Pseudoexfoliation Glaucoma, run by Vastra Gotaland Region at 2 sites in Sweden.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SLT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
2 sitesSweden
Study dates
10 Jan 2022to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sweden2 sites

  • Department of Ophthalmology, Skaraborg Hospital

    Skövde, Västra Götaland County, 54142

  • Department of Ophthalmology, NU Hospital Group

    Uddevalla, Västra Götaland County, 45153

Other trials in Sweden

About this study

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.

Read the detailed description

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.

Being tested
SLT
Keywords
Selective Laser Trabeculoplasty
Medical subject headings
Glaucoma, Open-Angle, Exfoliation Syndrome, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLTProcedure or surgery

    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).

Study groups in NCT05159960
Study groupRoleWhat they receive
180/lowExperimentalSLT 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.
Receives: Procedure: SLT
180/highExperimentalSLT 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.
Receives: Procedure: SLT
360/lowExperimentalSLT 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.
Receives: Procedure: SLT
360/highExperimentalSLT 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.
Receives: Procedure: SLT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (10)

  1. Survival (for each SLT iteration)

    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.

    Measured: 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.

  2. Survival (repeat SLT allowed)

    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.

    Measured: 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.

  3. Achievement of 20% reduction in IOP

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

    Measured: 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.

  4. Absolute IOP reduction for each SLT iteration

    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).

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

  5. Pain perioperatively: on a scale

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

    Measured: Immediately after treatment

  6. Pain postoperatively: on a scale

    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.

    Measured: During the first month

  7. Light sensitivity postoperatively: on a scale

    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.

    Measured: During the first month

  8. Impairment of vision postoperatively: on a scale

    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.

    Measured: During the first month

  9. Redness postoperatively: on a scale

    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.

    Measured: During the first month

  10. Adverse events

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start10 Jan 2022
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05159960
Sponsor's protocol ID
OSLT-R
Other IDs
277612
Acronym
OSLT-R
Status last verified
Sep 2025
First submitted
30 Nov 2021
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SLT in people with Glaucoma, Open-Angle and Pseudoexfoliation Glaucoma, run by Vastra Gotaland Region at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative IOP reduction for each SLT iteration (time frame: 1-6 months after each SLT, as described above). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05159960.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.

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