Primary Open Angle GlaucomaNCT07076303
A Prospective Study on the Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in Achieving >20% Intraocular Pressure (IOP) Reduction Without Medications at 6 Months in Naive, Untreated Glaucoma Patients
An observational study of Primary Open Angle Glaucoma and Glaucoma, run by Brian Shafer at 1 site in United States.
Trial summary
Background Glaucoma is a progressive optic neuropathy characterized by elevated intraocular pressure (IOP), leading to irreversible vision loss. Current treatment strategies often involve medications, which can be challenging for patients due to adherence issues and side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Glaucoma, Primary Open Angle Glaucoma or Ocular Hypertension
- What is being tested?
- Direct Selective Laser Trabuloplasty
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2002to 1 Jun 2026
- Phase
- Observational
- 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
Study population: Subjects 18 years or older who have primary open angle glaucoma or ocular hypertension who are treatment naïve.
Who may be able to join
- Adults aged 18 years or older:
- Participants must be adults, aged 18 years or older, to ensure they are capable of providing informed consent and to focus on adult-onset glaucoma. This age threshold allows the study to target a population where open-angle glaucoma typically manifests, avoiding potential variations in outcomes that might arise in younger populations with different types of ocular conditions.
- Diagnosis of naive, untreated open-angle glaucoma or similar conditions:
- The study is restricted to individuals who have been newly diagnosed with primary open-angle glaucoma and have not yet received any form of treatment, either pharmacological or surgical. This ensures that the effects of DSLT (Direct Selective Laser Trabeculoplasty) are evaluated without the confounding influence of prior treatments.
- Other similar conditions may include ocular hypertension or other early-stage glaucomatous conditions where IOP reduction is indicated (ie: pigment dispersion syndrome/glaucoma and pseudoexfoliation). This broadens the inclusion slightly to capture patients with conditions that have a similar disease mechanism and treatment goal, without including those with more complex or mixed forms of glaucoma.
Who cannot join
- Previous glaucoma surgeries/interventions:
- Patients who have undergone prior glaucoma-related surgeries (e.g., trabeculectomy, laser trabeculoplasty, or shunt procedures) or received other significant glaucoma interventions (such as long-term glaucoma medication use) are excluded. This criterion ensures the study evaluates the effect of DSLT in a treatment-naive population. Prior surgeries or interventions could bias the results by introducing variability in eye physiology, making it difficult to attribute outcomes solely to DSLT.
- Secondary glaucoma or other significant ocular conditions:
- Patients with secondary forms of glaucoma, such as angle-closure glaucoma, neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases, are excluded. These conditions often have different pathophysiological mechanisms, which could lead to varied responses to DSLT.
- Other significant ocular conditions that could interfere with the study include advanced cataracts, retinal diseases (e.g., age-related macular degeneration), or any condition that might complicate the assessment of intraocular pressure (IOP) or visual function. Excluding these conditions ensures a clearer evaluation of DSLT's effects on open-angle glaucoma without interference from unrelated ocular abnormalities.
- 3. Patients who are unable to fixate their head and/or eyes, such as patients suffering from uncontrolled nystagmus, tremors, or similar conditions.
- 4. Patients with a pupil that cannot constrict to a diameter of 4 mm or less.
- In summary, these criteria focus on a specific and controlled population of treatment-naive glaucoma patients to provide a clean evaluation of the effectiveness and safety of DSLT, while excluding individuals whose prior treatments or other conditions could skew the results.
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
Shafer Vision Institute
Plymouth Meeting, Pennsylvania, 19462
Brian Shafer, MD, 2156542020, brian.shafer@shafervision.com
Morgan O'Brien, 215 654 2020, morgan@shafervision.com
About this study
Background
Glaucoma is a progressive optic neuropathy characterized by elevated intraocular pressure (IOP), leading to irreversible vision loss. Current treatment strategies often involve medications, which can be challenging for patients due to adherence issues and side effects. Direct Selective Laser Trabeculoplasty (DSLT) represents a potential surgical alternative for managing IOP in patients with naive, untreated glaucoma. This study aims to evaluate the efficacy of DSLT in achieving significant IOP reduction without the need for postoperative medications.
Read more
Unmet Medical Need:
Overview of DSLT
Direct Selective Laser Trabeculoplasty (DSLT) is an emerging technology in glaucoma management that combines laser techniques to reduce intraocular pressure (IOP). While it works off the auspices of a previous technology (SLT), the method of delivery is significantly different.
Current Research Landscape
Most existing studies focus on patients who have already received other forms of treatment or who have more advanced glaucoma. This creates an unmet need to evaluate how DSLT can be effectively integrated into the management of patients at the very beginning of their glaucoma journey. Understanding its efficacy in this population is crucial for establishing best practices and improving long-term outcomes.
Interventional Glaucoma Management vs. Standard of Care
Standard of care for newly diagnosed glaucoma typically involves medications, such as topical prostaglandin analogs, which can have side effects and may not be effective for all patients. In contrast, interventional glaucoma management-such as DSLT-offers a potentially more direct approach to lowering IOP without the need for ongoing medication. Investigating DSLT in this context could lead to a paradigm shift in how newly diagnosed patients are managed, reducing their reliance on medications and potentially improving adherence and quality of life.
Conclusion
Addressing this research gap will not only help clarify the role of DSLT in early glaucoma management but could also enhance patient outcomes and guide future treatment protocols. Focusing on newly diagnosed patients is essential for determining the long-term benefits and risks associated with this innovative technology.
- Being tested
- Direct Selective Laser Trabuloplasty
- Keywords
- glaucoma, primary open angle glaucoma, direct SLT, SLT, selective laser trabeculoplasty
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Selective Laser TrabuloplastyDevice
Also called DSLT, Eagle DSLT
Eligible participants will undergo the DSLT procedure to facilitate controlled aqueous outflow. DSLT will consist of 120 shots, 400 µm spot size, energy 1.4-1.8 mJ delivered at the limbus over 2.4 seconds
| Study group | Role | What they receive |
|---|---|---|
| Primary Open Angle Glaucoma or Ocular Hypertension | Subjects with primary open angle glaucoma or ocular hypertension with baseline IOPs greater than 21mmHg. Receives: Device: Direct Selective Laser Trabuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Reduction in IOP from baseline at 6 months
Percent Reduction in IOP from baseline at 6 months
Measured: 6 months
Secondary outcomes (3)
Percentage of Eyes Achieving ≥ 20% Reduction in IOP at 6 months
The success rate of IOP reduction at 6 months, where success is defined as % of eyes achieving ≥20% reduction from baseline pre-treatment IOP.
Measured: 6 months
IOP reduction from baseline at 1 and 3 months
Percentage IOP reduction from baseline at 1 and 3 months
Measured: 3 months
Rate of Secondary Interventions at 6 months
The rate of secondary interventions (e.g., additional treatment or procedures) at 6 months post-DSLT.
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 posted22 Jul 2025
- Study start11 Mar 2002
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
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 Primary 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brian Shafer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian Shafer, Shafer Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076303
- Sponsor's protocol ID
- 95532219
- Status last verified
- Mar 2025
- First submitted
- 14 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The IPD is kept private at Shafer Vision Institute and is not available for outside access.
Publications
Congdon 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 34433548Goldenfeld 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 34003939
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in Achieving >20% Intraocular Pressure (IOP) Reduction Without Medications at 6 Months in Naive, Untreated Glaucoma Patients
- ClinicalTrials.gov ID
- NCT07076303
- Acronym / sponsor ID
- 95532219
- Keywords
- glaucoma, primary open angle glaucoma, direct SLT, SLT, selective laser trabeculoplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brian ShaferUniversity, hospital or other
- Study start
- 11 Mar 2002 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 22 Jul 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.
Background
Glaucoma is a progressive optic neuropathy characterized by elevated intraocular pressure (IOP), leading to irreversible vision loss. Current treatment strategies often involve medications, which can be challenging for patients due to adherence issues and side effects. Direct Selective Laser Trabeculoplasty (DSLT) represents a potential surgical alternative for managing IOP in patients with naive, untreated glaucoma. This study aims to evaluate the efficacy of DSLT in achieving significant IOP reduction without the need for postoperative medications.
Unmet Medical Need:
Overview of DSLT
Direct Selective Laser Trabeculoplasty (DSLT) is an emerging technology in glaucoma management that combines laser techniques to reduce intraocular pressure (IOP). While it works off the auspices of a previous technology (SLT), the method of delivery is significantly different.
Current Research Landscape
Most existing studies focus on patients who have already received other forms of treatment or who have more advanced glaucoma. This creates an unmet need to evaluate how DSLT can be effectively integrated into the management of patients at the very beginning of their glaucoma journey. Understanding its efficacy in this population is crucial for establishing best practices and improving long-term outcomes.
Interventional Glaucoma Management vs. Standard of Care
Standard of care for newly diagnosed glaucoma typically involves medications, such as topical prostaglandin analogs, which can have side effects and may not be effective for all patients. In contrast, interventional glaucoma management-such as DSLT-offers a potentially more direct approach to lowering IOP without the need for ongoing medication. Investigating DSLT in this context could lead to a paradigm shift in how newly diagnosed patients are managed, reducing their reliance on medications and potentially improving adherence and quality of life.
Conclusion
Addressing this research gap will not only help clarify the role of DSLT in early glaucoma management but could also enhance patient outcomes and guide future treatment protocols. Focusing on newly diagnosed patients is essential for determining the long-term benefits and risks associated with this innovative technology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Open Angle Glaucoma or Ocular Hypertension | – | Device: Direct Selective Laser TrabuloplastySubjects with primary open angle glaucoma or ocular hypertension with baseline IOPs greater than 21mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 18 years or older who have primary open angle glaucoma or ocular hypertension who are treatment naïve.
Key inclusion criteria (5 listed)
- Participants must be adults, aged 18 years or older, to ensure they are capable of providing informed consent and to focus on adult-onset glaucoma. This age threshold allows the study to target a population where open-angle glaucoma typically manifests, avoiding potential variations in outcomes that might arise in younger populations with different types of ocular conditions.
- The study is restricted to individuals who have been newly diagnosed with primary open-angle glaucoma and have not yet received any form of treatment, either pharmacological or surgical. This ensures that the effects of DSLT (Direct Selective Laser Trabeculoplasty) are evaluated without the confounding influence of prior treatments.
- Other similar conditions may include ocular hypertension or other early-stage glaucomatous conditions where IOP reduction is indicated (ie: pigment dispersion syndrome/glaucoma and pseudoexfoliation). This broadens the inclusion slightly to capture patients with conditions that have a similar disease mechanism and treatment goal, without including those with more complex or mixed forms of glaucoma.
Key exclusion criteria (8 listed)
- Patients who have undergone prior glaucoma-related surgeries (e.g., trabeculectomy, laser trabeculoplasty, or shunt procedures) or received other significant glaucoma interventions (such as long-term glaucoma medication use) are excluded. This criterion ensures the study evaluates the effect of DSLT in a treatment-naive population. Prior surgeries or interventions could bias the results by introducing variability in eye physiology, making it difficult to attribute outcomes solely to DSLT.
- Patients with secondary forms of glaucoma, such as angle-closure glaucoma, neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases, are excluded. These conditions often have different pathophysiological mechanisms, which could lead to varied responses to DSLT.
- Other significant ocular conditions that could interfere with the study include advanced cataracts, retinal diseases (e.g., age-related macular degeneration), or any condition that might complicate the assessment of intraocular pressure (IOP) or visual function. Excluding these conditions ensures a clearer evaluation of DSLT's effects on open-angle glaucoma without interference from unrelated ocular abnormalities.
- 3. Patients who are unable to fixate their head and/or eyes, such as patients suffering from uncontrolled nystagmus, tremors, or similar conditions.
- 4. Patients with a pupil that cannot constrict to a diameter of 4 mm or less.
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 Laser TrabuloplastyAlso: DSLT, Eagle DSLTEligible participants will undergo the DSLT procedure to facilitate controlled aqueous outflow. DSLT will consist of 120 shots, 400 µm spot size, energy 1.4-1.8 mJ delivered at the limbus over 2.4 seconds | Device | Primary Open Angle Glaucoma or Ocular Hypertension |
Primary outcome
Percent Reduction in IOP from baseline at 6 months
Time frame: 6 months
Percent Reduction in IOP from baseline at 6 months
3 secondary outcomes
Percentage of Eyes Achieving ≥ 20% Reduction in IOP at 6 months
Time frame: 6 months
IOP reduction from baseline at 1 and 3 months
Time frame: 3 months
Rate of Secondary Interventions at 6 months
Time frame: 6 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 22 Jul 2025.
- Background: 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.
- Background: 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.
- Individual participant dataSharing planned: No. The IPD is kept private at Shafer Vision Institute and is not available for outside access.
Related trials for Primary Open Angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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 recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma and Glaucoma, run by Brian Shafer 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 5 inclusion and 8 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 22 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 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 Brian Shafer, MD (2672102169, brian.shafer@shafervision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Reduction in IOP from baseline at 6 months (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 NCT07076303, 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 22 Jul 2025.