GlaucomaGLASSNCT06963684
Glaucoma Laser Assessment of Stability and Sustainability
A study testing Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT) in people with Glaucoma, run by Twin Cities Eye Consultants at 1 site in United States.
Trial summary
The GLASS Study is designed to help researchers learn whether repeating a non-invasive laser treatment called DSLT (Direct Selective Laser Trabeculoplasty) can better control eye pressure in patients with early-stage glaucoma or ocular hypertension. All participants will receive the laser treatment in both eyes. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Aug 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 40 years or older
- A bilateral diagnosis of ocular hypertension, glaucoma suspect, or mild primary open angle glaucoma as defined by AAO PPP
- Treatment naïve with an unmedicated IOP between 21-35 mmHg, inclusive, and within +/- 3mmHg of each eye to be eligible
- BCVA of 20/50 or better
- The subject is able to read and understand the requirements of the study and provide written informed consent.
- The subject is willing to follow study instructions, agrees to comply with all study procedures and attend all scheduled follow-up exams for 12 months after the initial treatment.
Who cannot join
- Unable to view scleral spur inferiorly with gonioscopy.
- Congenital or developmental glaucoma, angle closure glaucoma, secondary glaucoma (e.g. exfoliative, pigmentary, etc.) pigmentary, neovascular glaucoma, closed angle glaucoma, or uveitic glaucoma.
- Use of oral or ocular hypotensive medication for glaucoma.
- Prior history of ocular surgery except for cataract surgery (must be ≥ 2 years prior)
- Clinically significant ocular pathology, other than cataract and glaucoma, including but not limited to neovascular age-related macular degeneration, advanced dry macular degeneration, and proliferative diabetic retinopathy, etc.
- Clinically significant ocular inflammation or infection within 6 months prior to screening.
Show all 14Show fewer
- Previous corneal transplant or clinically significant corneal dystrophy, e.g., Fuch's dystrophy (≥12 confluent guttae)
- Unclear ocular media prevent visualization of the fundus or anterior chamber angle.
- Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's health at risk and/or prevent the subject from completing all study visits.
- Current participation in another investigational drug or device clinical trial (which includes the fellow eye) within the past 30 calendar days.
- Pregnant or nursing women; or women of childbearing age not using medically acceptable contraceptives.
- Accepted prior ocular procedures:
- Cataract surgery (if ≥ 2 years or screening)
- YAG capsulotomy (if ≥ 60 days of screening)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Twin Cities Eye Consultants
Coon Rapids, Minnesota, 55433
Study Coordinator, 612-999-2020, research@tcecmn.com
George R Wandling, MD
About this study
Official title: Glaucoma Laser Assessment of Stability and Sustainability: Evaluating Long-Term Stability and Retreatment Efficacy of DSLT in Patients With Ocular Hypertension, Glaucoma Suspects, and Mild/Moderate POAG.
The GLASS Study is designed to help researchers learn whether repeating a non-invasive laser treatment called DSLT (Direct Selective Laser Trabeculoplasty) can better control eye pressure in patients with early-stage glaucoma or ocular hypertension. All participants will receive the laser treatment in both eyes. After three months, one eye will be randomly selected to receive a second treatment, while the other eye will serve as a comparison. The goal is to see whether two treatments work better than one at keeping eye pressure low without using daily eye drops. This study will help doctors decide the best way to use this laser treatment to manage glaucoma and delay the need for medication. Participants will be followed for one year to monitor safety, eye pressure, and the need for any additional treatments.
Read the detailed description
The GLASS Study (Glaucoma Laser Assessment of Sequential Sessions) is a prospective, interventional, paired-eye, single-site, investigator-initiated clinical trial designed to evaluate the safety and effectiveness of repeated applications of Direct Selective Laser Trabeculoplasty (DSLT) in treatment-naive patients with ocular hypertension (OHT), glaucoma suspect, or mild to moderate primary open-angle glaucoma (POAG).
DSLT is a non-contact, automated laser procedure that delivers 120 laser pulses evenly around the limbus to stimulate aqueous outflow by targeting the trabecular meshwork. The procedure is performed with the patient in an upright seated position using the Voyager DSLT device (Alcon). Unlike conventional SLT, this method does not require gonioscopy, coupling gel, or a contact lens.
All enrolled subjects must be treatment-naive, meaning they have not previously been on any ocular hypotensive medications. Eligible subjects will first complete a screening visit to verify inclusion and exclusion criteria. If criteria are met, they will be enrolled and proceed to the Baseline visit, where both eyes will undergo DSLT.
At the 3-month visit, one randomly selected eye (the "dual-treatment eye") will undergo a second DSLT session. The fellow eye (the "single-treatment eye") will receive no further laser treatment and serve as a control. Subjects will continue follow-up visits at 4 months (1 month after the second treatment), 6 months, 9 months, and 12 months from the baseline treatment.
Each study visit will include assessments such as best-corrected visual acuity (BCVA), intraocular pressure (IOP) via Goldmann applanation tonometry, slit-lamp examination, adverse event monitoring, ocular medication review (if applicable), and specular microscopy to assess corneal endothelial cell density. The primary endpoint is the difference in mean IOP between the dual-treatment and single-treatment eyes at 12 months.
Secondary endpoints include change in IOP from baseline at each follow-up timepoint, time to re-initiation of ocular hypotensive medications, and any difference in safety or complication rates between the two eyes.
The hypothesis is that a second treatment at the 3-month mark will provide enhanced and more durable IOP reduction, possibly reducing or delaying the need for medication. While DSLT has been studied previously in single-treatment applications, this is the first prospective trial evaluating repeat bilateral DSLT in a paired-eye design using one eye as its own internal control.
All procedures will be conducted at Twin Cities Eye Consultants in Minnesota. The study is sponsored and monitored internally by Twin Cities Eye Consultants' Research Committee, who will oversee compliance, data integrity, and protocol adherence.
- Conditions
- Glaucoma
- Being tested
- Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT)
- Keywords
- DSLT, glaucoma, IOP, intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT)Device
This is the first clinical study to evaluate repeat bilateral Direct Selective Laser Trabeculoplasty (DSLT) in treatment-naïve patients, using a paired-eye design. Unlike prior SLT studies, which focused on monocular treatment or repeat treatment following IOP rebound, this study randomizes one eye to receive a second DSLT treatment three months after the first, while the fellow eye receives only a single treatment. This allows for a direct intra-subject comparison of efficacy and durability. Existing studies, including GLAUrious and LiGHT, suggest the potential benefits of repeat laser, but no data currently exist for early, scheduled repeat treatment with DSLT. This trial uniquely investigates whether proactively repeating the procedure in a controlled eye extends IOP reduction and delays or reduces the need for topical medications.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Dual DSLT Treatment | Experimental | This study consists of a single arm using a paired-eye design. All participants will receive DSLT treatment in both eyes at Baseling. Then, one randomized eye receives a second DSLT treatment three months after the first. Receives: Device: Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Decrease in Intraocular Pressure (IOP) from Baseline
Mean IOP reduction from untreated baseline (T0) to 3 months following bilateral DSLT, averaged between both eyes at the two timepoints.
Measured: Baseline to Month 3
Secondary outcomes (4)
Mean IOP at 6 Months Post-DSLT Initiation
Comparison of mean IOP between the once-treated eye and the twice-treated eye at 6 months.
Measured: Month 6
Proportion of Eyes Requiring No Additional Treatment
Proportion of eyes that remain drop-free and do not require additional glaucoma treatment at 6 and 12 months, comparing once- vs. twice-treated eyes.
Measured: Month 6 and Month 12
Mean IOP at 12 Months Post-DSLT Initiation
Comparison of mean IOP between the once-treated eye and the twice-treated eye at 12 months.
Measured: Month 12
Mean Percent Reduction in IOP from Baseline
Mean percentage reduction in IOP from baseline to 6 and 12 months, comparing once- vs. twice-treated eyes.
Measured: Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive DSLT treatment in both eyes at Baseline. 3-months later, one eye will be randomized to receive a second DSLT treatment. The primary endpoint is the difference in mean IOP between the dual-treatment and single-treatment eyes at 12 months.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Twin Cities Eye Consultants
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- George R Wandling, MD, Principal investigator, Twin Cities Eye Consultants - Partner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963684
- Sponsor's protocol ID
- TCEC-003
- Acronym
- GLASS
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Guo, Y., Ioannidou, A., & Jute, P. (2019). Selective laser trabeculoplasty: a review of repeatability. Annals Of Eye Science, 4(4), 20. doi:10.21037/aes.2019.05.01
Polat J, Grantham L, Mitchell K, Realini T. Repeatability of selective laser trabeculoplasty. Br J Ophthalmol. 2016 Oct;100(10):1437-41. doi: 10.1136/bjophthalmol-2015-307486. Epub 2016 Feb 1.
PubMed 26834070Durr GM, Harasymowycz P. The effect of repeat 360-degree selective laser trabeculoplasty on intraocular pressure control in open-angle glaucoma. J Fr Ophtalmol. 2016 Mar;39(3):261-4. doi: 10.1016/j.jfo.2015.10.008. Epub 2016 Mar 16.
PubMed 26995075Jang HJ, Yu B, Hodge W, Malvankar-Mehta MS. Repeat Selective Laser Trabeculoplasty for Glaucoma Patients: A Systematic Review and Meta-analysis. J Curr Glaucoma Pract. 2021 Sep-Dec;15(3):117-124. doi: 10.5005/jp-journals-10078-1302.
PubMed 35173393
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma Laser Assessment of Stability and Sustainability: Evaluating Long-Term Stability and Retreatment Efficacy of DSLT in Patients With Ocular Hypertension, Glaucoma Suspects, and Mild/Moderate POAG.
- ClinicalTrials.gov ID
- NCT06963684
- Acronym / sponsor ID
- GLASS / TCEC-003
- Conditions
- Glaucoma
- Keywords
- DSLT, glaucoma, IOP, intraocular pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Twin Cities Eye ConsultantsUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 9 May 2025 (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.
The GLASS Study is designed to help researchers learn whether repeating a non-invasive laser treatment called DSLT (Direct Selective Laser Trabeculoplasty) can better control eye pressure in patients with early-stage glaucoma or ocular hypertension. All participants will receive the laser treatment in both eyes. After three months, one eye will be randomly selected to receive a second treatment, while the other eye will serve as a comparison. The goal is to see whether two treatments work better than one at keeping eye pressure low without using daily eye drops. This study will help doctors decide the best way to use this laser treatment to manage glaucoma and delay the need for medication. Participants will be followed for one year to monitor safety, eye pressure, and the need for any additional treatments.
Detailed description
The GLASS Study (Glaucoma Laser Assessment of Sequential Sessions) is a prospective, interventional, paired-eye, single-site, investigator-initiated clinical trial designed to evaluate the safety and effectiveness of repeated applications of Direct Selective Laser Trabeculoplasty (DSLT) in treatment-naive patients with ocular hypertension (OHT), glaucoma suspect, or mild to moderate primary open-angle glaucoma (POAG).
DSLT is a non-contact, automated laser procedure that delivers 120 laser pulses evenly around the limbus to stimulate aqueous outflow by targeting the trabecular meshwork. The procedure is performed with the patient in an upright seated position using the Voyager DSLT device (Alcon). Unlike conventional SLT, this method does not require gonioscopy, coupling gel, or a contact lens.
All enrolled subjects must be treatment-naive, meaning they have not previously been on any ocular hypotensive medications. Eligible subjects will first complete a screening visit to verify inclusion and exclusion criteria. If criteria are met, they will be enrolled and proceed to the Baseline visit, where both eyes will undergo DSLT.
At the 3-month visit, one randomly selected eye (the "dual-treatment eye") will undergo a second DSLT session. The fellow eye (the "single-treatment eye") will receive no further laser treatment and serve as a control. Subjects will continue follow-up visits at 4 months (1 month after the second treatment), 6 months, 9 months, and 12 months from the baseline treatment.
Each study visit will include assessments such as best-corrected visual acuity (BCVA), intraocular pressure (IOP) via Goldmann applanation tonometry, slit-lamp examination, adverse event monitoring, ocular medication review (if applicable), and specular microscopy to assess corneal endothelial cell density. The primary endpoint is the difference in mean IOP between the dual-treatment and single-treatment eyes at 12 months.
Secondary endpoints include change in IOP from baseline at each follow-up timepoint, time to re-initiation of ocular hypotensive medications, and any difference in safety or complication rates between the two eyes.
The hypothesis is that a second treatment at the 3-month mark will provide enhanced and more durable IOP reduction, possibly reducing or delaying the need for medication. While DSLT has been studied previously in single-treatment applications, this is the first prospective trial evaluating repeat bilateral DSLT in a paired-eye design using one eye as its own internal control.
All procedures will be conducted at Twin Cities Eye Consultants in Minnesota. The study is sponsored and monitored internally by Twin Cities Eye Consultants' Research Committee, who will oversee compliance, data integrity, and protocol adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive DSLT treatment in both eyes at Baseline. 3-months later, one eye will be randomized to receive a second DSLT treatment. The primary endpoint is the difference in mean IOP between the dual-treatment and single-treatment eyes at 12 months.
| Arm | Type | Receives |
|---|---|---|
| Experimental - Dual DSLT Treatment | Experimental | Device: Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT)This study consists of a single arm using a paired-eye design. All participants will receive DSLT treatment in both eyes at Baseling. Then, one randomized eye receives a second DSLT treatment three months after the first. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients aged 40 years or older
- A bilateral diagnosis of ocular hypertension, glaucoma suspect, or mild primary open angle glaucoma as defined by AAO PPP
- Treatment naïve with an unmedicated IOP between 21-35 mmHg, inclusive, and within +/- 3mmHg of each eye to be eligible
- BCVA of 20/50 or better
- The subject is able to read and understand the requirements of the study and provide written informed consent.
Key exclusion criteria (14 listed)
- Unable to view scleral spur inferiorly with gonioscopy.
- Congenital or developmental glaucoma, angle closure glaucoma, secondary glaucoma (e.g. exfoliative, pigmentary, etc.) pigmentary, neovascular glaucoma, closed angle glaucoma, or uveitic glaucoma.
- Use of oral or ocular hypotensive medication for glaucoma.
- Prior history of ocular surgery except for cataract surgery (must be ≥ 2 years prior)
- Clinically significant ocular pathology, other than cataract and glaucoma, including but not limited to neovascular age-related macular degeneration, advanced dry macular degeneration, and proliferative diabetic retinopathy, etc.
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 |
|---|---|---|
| Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT)This is the first clinical study to evaluate repeat bilateral Direct Selective Laser Trabeculoplasty (DSLT) in treatment-naïve patients, using a paired-eye design. Unlike prior SLT studies, which focused on monocular treatment or repeat treatment following IOP rebound, this study randomizes one eye to receive a second DSLT treatment three months after the first, while the fellow eye receives only a single treatment. This allows for a direct intra-subject comparison of efficacy and durability. Existing studies, including GLAUrious and LiGHT, suggest the potential benefits of repeat laser, but no data currently exist for early, scheduled repeat treatment with DSLT. This trial uniquely investigates whether proactively repeating the procedure in a controlled eye extends IOP reduction and delays or reduces the need for topical medications. | Device | Experimental - Dual DSLT Treatment |
Primary outcome
Mean Decrease in Intraocular Pressure (IOP) from Baseline
Time frame: Baseline to Month 3
Mean IOP reduction from untreated baseline (T0) to 3 months following bilateral DSLT, averaged between both eyes at the two timepoints.
4 secondary outcomes
Mean IOP at 6 Months Post-DSLT Initiation
Time frame: Month 6
Proportion of Eyes Requiring No Additional Treatment
Time frame: Month 6 and Month 12
Mean IOP at 12 Months Post-DSLT Initiation
Time frame: Month 12
Mean Percent Reduction in IOP from Baseline
Time frame: Month 6 and Month 12
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 14 May 2025.
- BackgroundGuo, Y., Ioannidou, A., & Jute, P. (2019). Selective laser trabeculoplasty: a review of repeatability. Annals Of Eye Science, 4(4), 20. doi:10.21037/aes.2019.05.01
- Background: PubMed 26834070Polat J, Grantham L, Mitchell K, Realini T. Repeatability of selective laser trabeculoplasty. Br J Ophthalmol. 2016 Oct;100(10):1437-41. doi: 10.1136/bjophthalmol-2015-307486. Epub 2016 Feb 1.
- Background: PubMed 26995075Durr GM, Harasymowycz P. The effect of repeat 360-degree selective laser trabeculoplasty on intraocular pressure control in open-angle glaucoma. J Fr Ophtalmol. 2016 Mar;39(3):261-4. doi: 10.1016/j.jfo.2015.10.008. Epub 2016 Mar 16.
- Background: PubMed 35173393Jang HJ, Yu B, Hodge W, Malvankar-Mehta MS. Repeat Selective Laser Trabeculoplasty for Glaucoma Patients: A Systematic Review and Meta-analysis. J Curr Glaucoma Pract. 2021 Sep-Dec;15(3):117-124. doi: 10.5005/jp-journals-10078-1302.
- 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.
George R Wandling, MD principal investigator
Twin Cities Eye Consultants - Partner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-Treatment Direct Selective Laser Trabeculoplasty (DSLT) in people with Glaucoma, run by Twin Cities Eye Consultants at 1 site in United States.
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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Contact Hannah Schoenecker (612-999-2020, research@tcecmn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Decrease in Intraocular Pressure (IOP) from Baseline (time frame: Baseline to Month 3). 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 NCT06963684, which also lists 4 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 14 May 2025.