Open Angle GlaucomaGLAUriousNCT03750201
A Study to Assess an Automated Laser Device for Direct Selective Laser Trabeculoplasty
A study testing Direct Selective Trabeculoplasty and Selective Trabeculoplasty in people with Open Angle Glaucoma and Ocular Hypertension, run by BelkinVision at 8 sites in 3 countries.
Trial summary
Glaucoma is an eye disease that results in damage to the optic nerve that progresses over time. One of the main risk factors in glaucoma is an increase in intraocular pressure, caused by a build-up of fluid in the eye. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Direct Selective Trabeculoplasty and Selective Trabeculoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 19 Oct 2018to 22 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 years or older, with visual acuity > 6/60 in both eyes
- Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension
- IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications)
- Gonioscopically visible scleral spur for 360 degrees without indentation
- Ability to visualize the peri-limbal sclera for 360 degrees (using a lid speculum)
- Willing and able to participate in the 12-month study, to comply with the study procedures and to adhere to the follow-up schedule
- Participant capable of giving informed consent
Who cannot join
- Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities, etc.)
- Angle Closure Glaucoma
- Congenital or developmental glaucoma
- Secondary glaucoma except exfoliative or pigmentary glaucoma
- Presence of any Peripheral Anterior Synechiae (PAS) in the study eye
- Inability to conduct a reliable visual field (defined as fixation losses, false positives or false negatives greater than 33%)
Show all 26Show fewer
- Any of the following visual field findings using the Humphrey visual field analyzer the SITA-standard 24-2 program:
- A visual field MD of worse than -12dB
- Greater than or equal to 75% of points depressed below the 5% level and greater than or equal to 50% of points depressed below the 1% level on the PD plot
- At least 50% of points (i.e 2 or more) within the central 5 degrees with a sensitivity ≤0dB on the decibel plot
- Points within the central 5 degrees of fixation with a sensitivity <15 dB in both hemifields on the decibel plot
- A visual field MD of worse than -12dB in the fellow eye
- Cup:Disc Ratio of more than 0.8
- More than three hypotensive mediations required
- Prior incisional or laser glaucoma surgery (including previous SLT) in the study eye
- Prior corneal refractive surgery
- Complicated cataract surgery ≤ 6 months prior to enrollment
- Presence of visually significant cataract in the opinion of the investigator
- Clinically significant disease in either eye as determined by the Investigator
- Clinically significant amblyopia in either eye
- Dense pigmentation or haemorrhage in the peri-limbal conjunctiva or anterior sclera
- Women who are pregnant or may become pregnant during the study
- In the opinion of the investigator the participant might require other ocular surgery within the 12-month follow-up period, unless for further reduction of their IOP
- Concurrent treatment with topical, nasal, inhaled or systemic steroids
- Uncontrolled systemic disease that could impact the ability of the participant to attend follow up visits as per the discretion of the investigator
- Participation in another clinical study
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Israel5 sites
Soroka Medical Center
Beersheba
Rambam Medical Center
Haifa
Wolfson Medical Center
Holon
Shaare Zedek Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
United Kingdom2 sites
Queens University Belfast
Belfast
Moorfields Eye Hospital
London, EC1V 2PD
About this study
Official title: Direct Selective Laser Trabeculoplasty (DSLT) In Open Angle Glaucoma (POAG): A Randomized Controlled Trial
Glaucoma is an eye disease that results in damage to the optic nerve that progresses over time. One of the main risk factors in glaucoma is an increase in intraocular pressure, caused by a build-up of fluid in the eye. Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition.
Selective Laser Trabeculoplasty (SLT) is a laser treatment that facilitates the outflow of fluid from inside the eye. This has the potential of reducing the intraocular pressure within the eye (the main way in which this disease is treated since there is no cure) and may assist in helping to control the progression of this disease.
Read more
SLT (standard treatment) is a technique routinely carried out by glaucoma specialists. It is conducted using a special type of lens (goniolens) that gently sits on the front surface of the eye. The procedure takes approximately 5 minutes in duration.
This new treatment, Direct Selective Laser Trabeculoplasty (DSLT) is performed directly, without there being any need to use a goniolens which sits on the eye, and it is a shorter and simpler technique to conduct when compared to the standard SLT technique.
The purpose of this study is to assess the hypothesis that the treatment by new automated device for DSLT is not worse in comparison with the standard SLT and determine that it is effective in reducing intraocular pressure.
Read the detailed description
Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition.
Usually doctors treat the first symptoms of glaucoma or ocular hypertension by prescribing eye drops. Unfortunately, there can be side effects associated with the use of these eye drops and there are reports of non-compliance due to difficulties in inserting these drops, all of which can impact on how effective this treatment regimen is.
The purpose of this study is to assess how well the new automated DSLT device for laser treatment of glaucoma or ocular hypertension works in comparison with the standard SLT and determine that it is as effective in reducing intraocular pressure.
DSLT or SLT will be performed in the study eye according to the randomization assignment. Eligible patients who sign the informed consent will be enrolled at each of the study sites, and undergo a washout (in the case of being medicated). After washout there will be a baseline visit, where continued eligibility is confirmed. Following confirmation of continued eligibility, 50% of patients being randomized to each treatment group. Randomization will be to a pre-determined randomization list.
The un-masked investigator(s) will open the envelope corresponding to the subject ID and administer the treatment as indicated by the randomization envelope. The masked ophthalmologist(s), who will perform the follow up, will be masked as to the nature of the treatment the patient underwent.
Only one eye per participant will be included in the study and they will be treated using either DSLT or SLT as per the randomized treatment allocation.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Direct Selective Trabeculoplasty, Selective Trabeculoplasty
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Selective TrabeculoplastyDevice
Laser surgery by automated direct automated SLT device to lower intraocular pressure
Selective TrabeculoplastyDevice
Laser surgery by standard SLT device to lower intraocular pressure
| Study group | Role | What they receive |
|---|---|---|
| Direct Selective Trabeculoplasty | Experimental | Treatment by the investigational device. Receives: Device: Direct Selective Trabeculoplasty |
| Selective Trabeculoplasty | Active comparator | Treatment by the comparator device. Receives: Device: Selective Trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment
The mean baseline IOP (washed out for medicated patients) will be compared to the mean (washed out for medicated patients) IOP after the treatment
Measured: 6 months
Secondary outcomes (2)
Number of medications as compare to screening visit
Number of medications at 6 months as compared to screening/Visit 1 (before treatment) and compared between groups.
Measured: 6 months
Proportion of subjects with at least 20% reduction in IOP from baseline
Proportion of subjects with at least 20% reduction in IOP at 6 months compared to baseline without surgical intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start19 Oct 2018
- Primary completion15 Apr 2022
- Study completion22 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- BelkinVision
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission, Universita degli Studi di Genova, Queen's University, Belfast, Moorfields Eye Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Nathan Congdon, MD, MPH, Principal investigator, Queens University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750201
- Sponsor's protocol ID
- GLAUrious-2017-01
- Acronym
- GLAUrious
- Status last verified
- Jul 2021
- First submitted
- 19 Nov 2018
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gazzard G, Congdon N, Azuara-Blanco A, Blumenthal EZ, Gomelauri K, Zaliniyan M, Traverso CE, Bracha Z, Dvalishvili A, Solberg Y, Belkin M, Samuelson TW; GLAUrious Study Group. Randomized Noninferiority Trial of Direct Selective Laser Trabeculoplasty in Open-Angle Glaucoma and Ocular Hypertension: GLAUrious Study. Ophthalmology. 2025 Oct;132(10):1091-1104. doi: 10.1016/j.ophtha.2025.05.004. Epub 2025 May 9.
PubMed 40350086Congdon N, Azuara-Blanco A, Solberg Y, Traverso CE, Iester M, Cutolo CA, Bagnis A, Aung T, Fudemberg SJ, Lindstrom R, Samuelson T, Singh K, Blumenthal EZ, Gazzard G; GLAUrious study group. Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious). Br J Ophthalmol. 2023 Jan;107(1):62-65. doi: 10.1136/bjophthalmol-2021-319379. Epub 2021 Aug 25.
PubMed 34433548
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Selective Laser Trabeculoplasty (DSLT) In Open Angle Glaucoma (POAG): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03750201
- Acronym / sponsor ID
- GLAUrious / GLAUrious-2017-01
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- BelkinVisionIndustry (pharma, biotech, devices)
- Collaborators
- European Commission, Universita degli Studi di Genova, Queen's University, Belfast, Moorfields Eye Hospital NHS Foundation Trust
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 22 May 2022 (actual)
- First posted
- 21 Nov 2018 (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.
Glaucoma is an eye disease that results in damage to the optic nerve that progresses over time. One of the main risk factors in glaucoma is an increase in intraocular pressure, caused by a build-up of fluid in the eye. Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition.
Selective Laser Trabeculoplasty (SLT) is a laser treatment that facilitates the outflow of fluid from inside the eye. This has the potential of reducing the intraocular pressure within the eye (the main way in which this disease is treated since there is no cure) and may assist in helping to control the progression of this disease.
SLT (standard treatment) is a technique routinely carried out by glaucoma specialists. It is conducted using a special type of lens (goniolens) that gently sits on the front surface of the eye. The procedure takes approximately 5 minutes in duration.
This new treatment, Direct Selective Laser Trabeculoplasty (DSLT) is performed directly, without there being any need to use a goniolens which sits on the eye, and it is a shorter and simpler technique to conduct when compared to the standard SLT technique.
The purpose of this study is to assess the hypothesis that the treatment by new automated device for DSLT is not worse in comparison with the standard SLT and determine that it is effective in reducing intraocular pressure.
Detailed description
Glaucoma can result in blindness if left untreated and as such it is extremely important to diagnose and treat the condition.
Usually doctors treat the first symptoms of glaucoma or ocular hypertension by prescribing eye drops. Unfortunately, there can be side effects associated with the use of these eye drops and there are reports of non-compliance due to difficulties in inserting these drops, all of which can impact on how effective this treatment regimen is.
The purpose of this study is to assess how well the new automated DSLT device for laser treatment of glaucoma or ocular hypertension works in comparison with the standard SLT and determine that it is as effective in reducing intraocular pressure.
DSLT or SLT will be performed in the study eye according to the randomization assignment. Eligible patients who sign the informed consent will be enrolled at each of the study sites, and undergo a washout (in the case of being medicated). After washout there will be a baseline visit, where continued eligibility is confirmed. Following confirmation of continued eligibility, 50% of patients being randomized to each treatment group. Randomization will be to a pre-determined randomization list.
The un-masked investigator(s) will open the envelope corresponding to the subject ID and administer the treatment as indicated by the randomization envelope. The masked ophthalmologist(s), who will perform the follow up, will be masked as to the nature of the treatment the patient underwent.
Only one eye per participant will be included in the study and they will be treated using either DSLT or SLT as per the randomized treatment allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Selective Trabeculoplasty | Experimental | Device: Direct Selective TrabeculoplastyTreatment by the investigational device. |
| Selective Trabeculoplasty | Active comparator | Device: Selective TrabeculoplastyTreatment by the comparator device. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40 years or older, with visual acuity > 6/60 in both eyes
- Open angle glaucoma including exfoliative or pigmentary glaucoma or ocular hypertension
- IOP ≥ 22mmHg to ≤35mmHg (after washout of any IOP-lowering medications)
- Gonioscopically visible scleral spur for 360 degrees without indentation
- Ability to visualize the peri-limbal sclera for 360 degrees (using a lid speculum)
Key exclusion criteria (26 listed)
- Contraindications to conventional laser trabeculoplasty (e.g. corneal abnormalities, etc.)
- Angle Closure Glaucoma
- Congenital or developmental glaucoma
- Secondary glaucoma except exfoliative or pigmentary glaucoma
- Presence of any Peripheral Anterior Synechiae (PAS) in the study eye
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 |
|---|---|---|
| Direct Selective TrabeculoplastyLaser surgery by automated direct automated SLT device to lower intraocular pressure | Device | Direct Selective Trabeculoplasty |
| Selective TrabeculoplastyLaser surgery by standard SLT device to lower intraocular pressure | Device | Selective Trabeculoplasty |
Primary outcome
The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment
Time frame: 6 months
The mean baseline IOP (washed out for medicated patients) will be compared to the mean (washed out for medicated patients) IOP after the treatment
2 secondary outcomes
Number of medications as compare to screening visit
Time frame: 6 months
Proportion of subjects with at least 20% reduction in IOP from baseline
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 40350086Gazzard G, Congdon N, Azuara-Blanco A, Blumenthal EZ, Gomelauri K, Zaliniyan M, Traverso CE, Bracha Z, Dvalishvili A, Solberg Y, Belkin M, Samuelson TW; GLAUrious Study Group. Randomized Noninferiority Trial of Direct Selective Laser Trabeculoplasty in Open-Angle Glaucoma and Ocular Hypertension: GLAUrious Study. Ophthalmology. 2025 Oct;132(10):1091-1104. doi: 10.1016/j.ophtha.2025.05.004. Epub 2025 May 9.
- Derived from this study: PubMed 34433548Congdon N, Azuara-Blanco A, Solberg Y, Traverso CE, Iester M, Cutolo CA, Bagnis A, Aung T, Fudemberg SJ, Lindstrom R, Samuelson T, Singh K, Blumenthal EZ, Gazzard G; GLAUrious study group. Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious). Br J Ophthalmol. 2023 Jan;107(1):62-65. doi: 10.1136/bjophthalmol-2021-319379. Epub 2021 Aug 25.
- Link to the manuscript in OphthalmologyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nathan Congdon, MD, MPH principal investigator
Queens University Belfast
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct Selective Trabeculoplasty and Selective Trabeculoplasty in people with Open Angle Glaucoma and Ocular Hypertension, run by BelkinVision at 8 sites in 3 countries.
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 7 inclusion and 26 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: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Israel, United Kingdom, Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference between the two treatment groups between the mean baseline IOP and the mean IOP after the treatment (time frame: 6 months). 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 NCT03750201, which also lists 2 linked publications.
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 24 Jul 2025.