Glaucoma, Open-AngleOSLTNCT03798223
Optimal Treatment Protocol for Selective Laser Trabeculoplasty
A study testing SLT in people with Glaucoma, Open-Angle and Pseudoexfoliation Glaucoma, run by Vastra Gotaland Region at 4 sites in Sweden.
Trial summary
A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Pseudoexfoliation Glaucoma, Ocular Hypertension
- 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
- 4 sitesSweden
- Study dates
- 10 Jan 2019to 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Ogonkliniken, Sodra Alvsborgs Sjukhus
Borås, Västra Götaland County, 50182
Ogonkliniken, Sahlgrenska Universitetssjukhuset
Mölndal, Västra Götaland County, 43130
Ogonkliniken, Skaraborgs Sjukhus
Skövde, Västra Götaland County, 54142
Ogonkliniken NU-sjukvarden
Uddevalla, Västra Götaland County, 45153
About this study
A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.
Read the detailed description
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.
- 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 group | Role | What they receive |
|---|---|---|
| 180/standard | 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. Receives: 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. Receives: Procedure: SLT |
| 360/standard | 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. Receives: 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. Receives: Procedure: SLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: Before SLT and thereafter regularly for 4 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.
Measured: For 4 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).
Measured: For 4 years
Secondary outcomes (8)
Survival (SLT allowed)
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.
Measured: For 4 years
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
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
Light sensitivity postoperatively
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
Impairment of vision postoperatively
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
Redness postoperatively
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
Flare (inflammation measurement of the anterior chamber)
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.
Measured: Pre-operatively and then one day, one week and one month post-operatively.
Adverse events
The type and frequency of adverse events will be recorded and analyzed in each of the study arms.
Measured: 6 months after SLT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start10 Jan 2019
- Primary completion30 Apr 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Marcelo Ayala, MD, PhD, Study chair, Vastra Gotaland RegionTobias Dahlgren, MD, Principal investigator, Vastra Gotaland Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798223
- Sponsor's protocol ID
- Optimal SLT
- Other IDs
- 254861
- Acronym
- OSLT
- Status last verified
- Jul 2026
- First submitted
- 3 Jan 2019
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Treatment Protocol for Selective Laser Trabeculoplasty
- ClinicalTrials.gov ID
- NCT03798223
- Acronym / sponsor ID
- OSLT / Optimal SLT
- Keywords
- Selective Laser Trabeculoplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 180/standard | Experimental | Procedure: SLTSLT 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. |
| 180/high | Experimental | Procedure: SLTSLT 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. |
| 360/standard | Experimental | Procedure: SLTSLT 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. |
| 360/high | Experimental | Procedure: SLTSLT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLTA 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). | Procedure or surgery | 180/high, 180/standard, 360/high, 360/standard |
Primary outcome
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.
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.
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).
8 secondary outcomes
Survival (SLT allowed)
Time frame: For 4 years
Pain perioperatively: on a scale
Time frame: Immediately after treatment
Pain postoperatively: on a scale
Time frame: During the first month
Light sensitivity postoperatively
Time frame: During the first month
Impairment of vision postoperatively
Time frame: During the first month
Redness postoperatively
Time frame: During the first month
Flare (inflammation measurement of the anterior chamber)
Time frame: Pre-operatively and then one day, one week and one month post-operatively.
Adverse events
Time frame: 6 months after SLT.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Glaucoma, Open-Angle
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruiting
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
Primary Open Angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle
Not yet recruitingPhase 4
The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients
Glaucoma, Glaucoma, Open-Angle
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo Ayala, MD, PhD study chair
Vastra Gotaland Region
Tobias Dahlgren, MD principal investigator
Vastra Gotaland Region
4 sites in 1 country: see every site and its status.
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 4 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Change in intraocular pressure (IOP) (time frame: Before SLT and thereafter regularly for 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.