GLAUCOMA 1, OPEN ANGLE, D (Disorder)NCT06925477
Direct vs. Conventional SLT in Open-Angle Glaucoma: A RCT
A study testing DSLT treatment for Open-Angle Glaucoma and SLT treatment for Open-Angle Glaucoma in people with GLAUCOMA 1, OPEN ANGLE, D (Disorder), run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study compares two laser treatments for open-angle glaucoma: Selective Laser Trabeculoplasty (SLT) and Direct Selective Laser Trabeculoplasty (DSLT). SLT is a widely used procedure that requires a manual technique with a goniolens, while DSLT is a new, automated, non-contact method using the Eagle system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GLAUCOMA 1, OPEN ANGLE, D (Disorder)
- What is being tested?
- DSLT treatment for Open-Angle Glaucoma and SLT treatment for Open-Angle Glaucoma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to 30 Nov 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
- Age ≥18 years.
- Diagnosed with OAG (including exfoliative/pigmentary glaucoma) or OHT.
- Gonioscopically visible scleral spur for 360 degrees.
- Ability to provide informed consent.
- In good health, without prior laser trabeculoplasty, with decision to treat made by an ophthalmologist on the basis of risk profile, patient preference, or both.
- Each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes):
Show all 9Show fewer
- High-risk ocular hypertension (OHT): IOP > 21 mmHg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the neuroretinal rim, visible nerve fiber layer defects, or asymmetry of the vertical cup-to-disc ratio of >0.2 between eyes) [enrollment of trial participants with High-risk OHT will be capped at 25% of total enrollment]
- Mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation >-6.0 dB with no points in the central 5° <15 dB
- Moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation -6.0 dB to >-12 dB and no more than 1 central 5° point <15 dB
Who cannot join
- Advanced POAG in either eye
- Glaucoma other than OAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
- Mean IOP > 35 mmHg at either the screening or baseline visit in either eye
- Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
- Contraindications to SLT, brimonidine, apraclonidine, or any other study intervention
- Any corneal pathology that would preclude accurate assessment of IOP by Goldmann tonometry in either eye
Show all 10Show fewer
- Any intraocular surgical procedure within the past 6 months in either eye
- Inability to attend all scheduled study visits
- Pregnancy or plan to become pregnant in the next 1 year
- Any prior laser trabeculoplasty, including ALT, MLT and SLT.
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
MUSC Health West Ophthalmology Clinic
Charleston, South Carolina, 29407
About this study
Official title: Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT) in Reducing Intraocular Pressure in Open-Angle Glaucoma
This study compares two laser treatments for open-angle glaucoma: Selective Laser Trabeculoplasty (SLT) and Direct Selective Laser Trabeculoplasty (DSLT). SLT is a widely used procedure that requires a manual technique with a goniolens, while DSLT is a new, automated, non-contact method using the Eagle system. The study will evaluate whether DSLT is as effective as SLT in reducing intraocular pressure (IOP). Participants will be randomly assigned to receive either treatment and will be monitored over 12 months to assess changes in IOP, medication use, and safety outcomes. The goal is to determine if the simpler DSLT procedure can provide similar results to SLT, potentially improving patient comfort and access to glaucoma care.
Read the detailed description
Glaucoma management is fundamentally aimed at reducing intraocular pressure (IOP) to prevent optic nerve damage and preserve vision. Selective Laser Trabeculoplasty (SLT) has been a cornerstone in the treatment of open-angle glaucoma due to its efficacy and safety profile. However, SLT's manual delivery method using a goniolens can introduce variability, patient discomfort, and operator dependency.
Direct Selective Laser Trabeculoplasty (DSLT) represents an innovative advancement, offering a non-contact, automated laser treatment via the Eagle system. This technology is designed to simplify the procedure, enhance patient comfort, and minimize operator-induced variability. Early evidence suggests that DSLT may provide similar or improved IOP reduction compared to SLT, with a potentially better safety profile.
This study seeks to rigorously evaluate whether DSLT is non-inferior to SLT in reducing IOP, thus providing critical data on the efficacy and safety of this novel approach. Demonstrating non-inferiority would support broader adoption of DSLT, potentially improving patient outcomes and expanding access to effective glaucoma treatment.
- Conditions
- GLAUCOMA 1, OPEN ANGLE, D (Disorder)
- Being tested
- DSLT treatment for Open-Angle Glaucoma, SLT treatment for Open-Angle Glaucoma
- Keywords
- Open Angle Glaucoma, SLT, Trabeculoplasty, DSLT
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSLT treatment for Open-Angle GlaucomaDevice
This intervention aims to determine the efficacy and safety of Direct Selective Laser Trabeculoplasty (DSLT) in reducing intraocular pressure in patients with open-angle glaucoma.
SLT treatment for Open-Angle GlaucomaDevice
To determine the efficacy and safety of using Selective Laser Trabeculoplasty for treatment of open-angle glaucoma.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- DSLT (Direct Selective Laser Trabeculoplasty) | Other | DSLT is a well-established non-contact laser application that does not require a gonioscopy lens, reducing the risk of corneal damage and inflammation. Receives: Device: DSLT treatment for Open-Angle Glaucoma |
| Arm 2- Selective Laser Trabeculoplasty (SLT) | Other | SLT is a widely used and effective laser therapy to lower intraocular pressure that requires operator expertise and carries risks of mild inflammation, corneal damage and discomfort. This is a standard laser system that requires the use of a gonioscopy lens placed on the cornea to administer. Receives: Device: SLT treatment for Open-Angle Glaucoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Measuring the difference in the average IOP measurement reduction from the patient's baseline at 6 months between the DSLT and the SLT groups.
Measured: 6 months
Secondary outcomes (1)
Secondary Outcome
The patients percentage of IOP reduction at 2 months, 6 months, and 12 months. Measuring the amount of patient's that have achieved >/= 20% IOP reduction at 6 months. Documentation of any change in the use of ocular hypotensive medications at 12 months. Documentation of the rate of repeat laser treatments or additional IOP lowering procedures.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start7 Aug 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GLAUCOMA 1, OPEN ANGLE, D (Disorder)Studies 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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jella An, Medical University of South Carolina
- Investigators
- Jella An, MD, MBA, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925477
- Sponsor's protocol ID
- Pro00142923
- Status last verified
- Sep 2025
- First submitted
- 6 Apr 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Konstantakopoulou E, Gazzard G, Garway-Heath D, Adeleke M, Ambler G, Vickerstaff V, Bunce C, Nathwani N, Barton K; LiGHT Trial Study Group. Selective Laser Trabeculoplasty After Medical Treatment for Glaucoma or Ocular Hypertension. JAMA Ophthalmol. 2025 Apr 1;143(4):295-302. doi: 10.1001/jamaophthalmol.2024.6492.
PubMed 39976961Goldenfeld M, Belkin M, Dobkin-Bekman M, Sacks Z, Blum Meirovitch S, Geffen N, Leshno A, Skaat A. Automated Direct Selective Laser Trabeculoplasty: First Prospective Clinical Trial. Transl Vis Sci Technol. 2021 Mar 1;10(3):5. doi: 10.1167/tvst.10.3.5.
PubMed 34003939Melik Parsadaniantz S, Reaux-le Goazigo A, Sapienza A, Habas C, Baudouin C. Glaucoma: A Degenerative Optic Neuropathy Related to Neuroinflammation? Cells. 2020 Feb 25;9(3):535. doi: 10.3390/cells9030535.
PubMed 32106630
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Selective Laser Trabeculoplasty (DSLT) and Selective Laser Trabeculoplasty (SLT) in Reducing Intraocular Pressure in Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT06925477
- Acronym / sponsor ID
- Pro00142923
- Conditions
- GLAUCOMA 1, OPEN ANGLE, D (Disorder)
- Keywords
- Open Angle Glaucoma, SLT, Trabeculoplasty, DSLT
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 13 Apr 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.
This study compares two laser treatments for open-angle glaucoma: Selective Laser Trabeculoplasty (SLT) and Direct Selective Laser Trabeculoplasty (DSLT). SLT is a widely used procedure that requires a manual technique with a goniolens, while DSLT is a new, automated, non-contact method using the Eagle system. The study will evaluate whether DSLT is as effective as SLT in reducing intraocular pressure (IOP). Participants will be randomly assigned to receive either treatment and will be monitored over 12 months to assess changes in IOP, medication use, and safety outcomes. The goal is to determine if the simpler DSLT procedure can provide similar results to SLT, potentially improving patient comfort and access to glaucoma care.
Detailed description
Glaucoma management is fundamentally aimed at reducing intraocular pressure (IOP) to prevent optic nerve damage and preserve vision. Selective Laser Trabeculoplasty (SLT) has been a cornerstone in the treatment of open-angle glaucoma due to its efficacy and safety profile. However, SLT's manual delivery method using a goniolens can introduce variability, patient discomfort, and operator dependency.
Direct Selective Laser Trabeculoplasty (DSLT) represents an innovative advancement, offering a non-contact, automated laser treatment via the Eagle system. This technology is designed to simplify the procedure, enhance patient comfort, and minimize operator-induced variability. Early evidence suggests that DSLT may provide similar or improved IOP reduction compared to SLT, with a potentially better safety profile.
This study seeks to rigorously evaluate whether DSLT is non-inferior to SLT in reducing IOP, thus providing critical data on the efficacy and safety of this novel approach. Demonstrating non-inferiority would support broader adoption of DSLT, potentially improving patient outcomes and expanding access to effective glaucoma treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1- DSLT (Direct Selective Laser Trabeculoplasty) | Other | Device: DSLT treatment for Open-Angle GlaucomaDSLT is a well-established non-contact laser application that does not require a gonioscopy lens, reducing the risk of corneal damage and inflammation. |
| Arm 2- Selective Laser Trabeculoplasty (SLT) | Other | Device: SLT treatment for Open-Angle GlaucomaSLT is a widely used and effective laser therapy to lower intraocular pressure that requires operator expertise and carries risks of mild inflammation, corneal damage and discomfort. This is a standard laser system that requires the use of a gonioscopy lens placed on the cornea to administer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years.
- Diagnosed with OAG (including exfoliative/pigmentary glaucoma) or OHT.
- Gonioscopically visible scleral spur for 360 degrees.
- Ability to provide informed consent.
- In good health, without prior laser trabeculoplasty, with decision to treat made by an ophthalmologist on the basis of risk profile, patient preference, or both.
Key exclusion criteria (10 listed)
- Advanced POAG in either eye
- Glaucoma other than OAG (including pigmentary and pseudoexfoliation glaucoma) in either eye
- Mean IOP > 35 mmHg at either the screening or baseline visit in either eye
- Narrow or closed angle (Shaffer Grade 0, 1, or 2) in either eye
- Contraindications to SLT, brimonidine, apraclonidine, or any other study intervention
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 |
|---|---|---|
| DSLT treatment for Open-Angle GlaucomaThis intervention aims to determine the efficacy and safety of Direct Selective Laser Trabeculoplasty (DSLT) in reducing intraocular pressure in patients with open-angle glaucoma. | Device | Arm 1- DSLT (Direct Selective Laser Trabeculoplasty) |
| SLT treatment for Open-Angle GlaucomaTo determine the efficacy and safety of using Selective Laser Trabeculoplasty for treatment of open-angle glaucoma. | Device | Arm 2- Selective Laser Trabeculoplasty (SLT) |
Primary outcome
Primary Endpoint
Time frame: 6 months
Measuring the difference in the average IOP measurement reduction from the patient's baseline at 6 months between the DSLT and the SLT groups.
1 secondary outcome
Secondary Outcome
Time frame: 12 months
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 Sep 2026.
- Results publication: PubMed 39976961Konstantakopoulou E, Gazzard G, Garway-Heath D, Adeleke M, Ambler G, Vickerstaff V, Bunce C, Nathwani N, Barton K; LiGHT Trial Study Group. Selective Laser Trabeculoplasty After Medical Treatment for Glaucoma or Ocular Hypertension. JAMA Ophthalmol. 2025 Apr 1;143(4):295-302. doi: 10.1001/jamaophthalmol.2024.6492.
- Results publication: PubMed 34003939Goldenfeld M, Belkin M, Dobkin-Bekman M, Sacks Z, Blum Meirovitch S, Geffen N, Leshno A, Skaat A. Automated Direct Selective Laser Trabeculoplasty: First Prospective Clinical Trial. Transl Vis Sci Technol. 2021 Mar 1;10(3):5. doi: 10.1167/tvst.10.3.5.
- Results publication: PubMed 32106630Melik Parsadaniantz S, Reaux-le Goazigo A, Sapienza A, Habas C, Baudouin C. Glaucoma: A Degenerative Optic Neuropathy Related to Neuroinflammation? Cells. 2020 Feb 25;9(3):535. doi: 10.3390/cells9030535.
- Individual participant dataSharing planned: Undecided
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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.
Jella An, MD, MBA principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSLT treatment for Open-Angle Glaucoma and SLT treatment for Open-Angle Glaucoma in people with GLAUCOMA 1, OPEN ANGLE, D (Disorder), run by Medical University of South Carolina 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 9 inclusion and 10 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 14 Sep 2026. 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?
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?
Primary Endpoint (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 NCT06925477, which also lists 3 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 Sep 2026.