Primary Open Angle GlaucomaNCT07390890
DSLT for Reducing Medication in Glaucoma
An observational study of Primary Open Angle Glaucoma and Ocular Hypertension, run by The Eye Institute of West Florida at 1 site in United States.
Trial summary
This is a prospective, single arm, open label study conducted at a single site to evaluate the efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in reducing medication burden in patients with medically controlled ocular hypertension or primary open angle glaucoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Voyager DSLT
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to 26 Jan 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults with ocular hypertension or POAG undergoing DSLT treatment in one or both eyes.
Who may be able to join
- Adult patients scheduled to undergo DSLT treatment in one or both eyes.
- Diagnosis of ocular hypertension or primary open angle glaucoma (POAG).
- Medically controlled on 1-3 topical ocular hypotensive agents with IOP ≤21 mmHg.
Who cannot join
- Previous glaucoma surgeries/interventions:
- Patients who have undergone prior glaucoma-related procedures (e.g., trabeculectomy, laser trabeculoplasty, MIGS, or tube shunt).
- Patients who have undergone cataract surgery within the prior 2 years.
- Secondary glaucoma:
- Patients with secondary forms of glaucoma, such as angle-closure glaucoma, neovascular glaucoma, or glaucoma resulting from trauma or other systemic diseases.
- Other significant ocular conditions including 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 as deemed by the investigator.
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
The Eye Institute of West Florida
Largo, Florida, 33770
Renee Bondurant, 727-450-4668, Renee.Bondurant@eyespecialist.com
Neel Desai, MD
About this study
Official title: Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Medication Burden in Medically Controlled Patients With Ocular Hypertension or Primary Open Angle Glaucoma
This is a prospective, single arm, open label study conducted at a single site to evaluate the efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in reducing medication burden in patients with medically controlled ocular hypertension or primary open angle glaucoma.
The study will assess the primary endpoint of reduction in medication count at 6 months compared to baseline. Secondary endpoints include IOP reduction compared to baseline (both percentage and absolute), complete success rate (no increase in IOP without medications), proportion of eyes needing medication at 6 months, and any secondary surgical interventions at 6 months post-DSLT.
Participants will undergo DSLT with 120 shots, 400 µm spot size, and 1.8mJ fixed energy delivered at the limbus over 2.4 seconds. Follow-up visits will occur at 1 month, 3 months, and 6 months post-procedure, with IOP measured using a calibrated Goldmann tonometer.
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Voyager DSLT
- 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.
Voyager DSLTDevice
Voyager DSLT
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of glaucoma medications required to maintain target intraocular pressure (IOP)
The primary outcome will be assessed by comparing the number of medications needed to maintain target IOP before and after DSLT treatment.
Measured: 6 months post-DSLT treatment
Secondary outcomes (3)
Change in intraocular pressure (IOP) from baseline
IOP will be measured using Goldmann applanation tonometry at each follow-up visit.
Measured: 6 months post-DSLT treatment
Proportion of eyes needing medication stratified by number of IOP medications required
Measured: 6 months post-DSLT treatment
Number and type of Secondary surgical interventions
Measured: 6 months post-DSLT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start10 Feb 2026
- Primary completion26 Jan 2027 (estimated)
- Study completion26 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- The Eye Institute of West Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Neel Desai, MD, Principal investigator, The Eye Institute of West Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390890
- Sponsor's protocol ID
- ND-25-01
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Medication Burden in Medically Controlled Patients With Ocular Hypertension or Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT07390890
- Acronym / sponsor ID
- ND-25-01
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Eye Institute of West FloridaUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 26 Jan 2027 (estimated)
- Study completion
- 26 Jan 2027 (estimated)
- First posted
- 5 Feb 2026 (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 is a prospective, single arm, open label study conducted at a single site to evaluate the efficacy of Direct Selective Laser Trabeculoplasty (DSLT) in reducing medication burden in patients with medically controlled ocular hypertension or primary open angle glaucoma.
The study will assess the primary endpoint of reduction in medication count at 6 months compared to baseline. Secondary endpoints include IOP reduction compared to baseline (both percentage and absolute), complete success rate (no increase in IOP without medications), proportion of eyes needing medication at 6 months, and any secondary surgical interventions at 6 months post-DSLT.
Participants will undergo DSLT with 120 shots, 400 µm spot size, and 1.8mJ fixed energy delivered at the limbus over 2.4 seconds. Follow-up visits will occur at 1 month, 3 months, and 6 months post-procedure, with IOP measured using a calibrated Goldmann tonometer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults with ocular hypertension or POAG undergoing DSLT treatment in one or both eyes.
Key inclusion criteria (3 listed)
- Adult patients scheduled to undergo DSLT treatment in one or both eyes.
- Medically controlled on 1-3 topical ocular hypotensive agents with IOP ≤21 mmHg.
Key exclusion criteria (6 listed)
- Previous glaucoma surgeries/interventions:
- Patients who have undergone cataract surgery within the prior 2 years.
- Secondary glaucoma:
- Other significant ocular conditions including 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 as deemed by the investigator.
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 |
|---|---|---|
| Voyager DSLTVoyager DSLT | Device | – |
Primary outcome
Reduction in the number of glaucoma medications required to maintain target intraocular pressure (IOP)
Time frame: 6 months post-DSLT treatment
The primary outcome will be assessed by comparing the number of medications needed to maintain target IOP before and after DSLT treatment.
3 secondary outcomes
Change in intraocular pressure (IOP) from baseline
Time frame: 6 months post-DSLT treatment
Proportion of eyes needing medication stratified by number of IOP medications required
Time frame: 6 months post-DSLT treatment
Number and type of Secondary surgical interventions
Time frame: 6 months post-DSLT treatment
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 20 Apr 2026.
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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.
Neel Desai, MD principal investigator
The Eye Institute of West Florida
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 Ocular Hypertension, run by The Eye Institute of West Florida 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 3 inclusion and 6 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 20 Apr 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?
Contact Renee Bondurant (727-450-4668, Renee.Bondurant@eyespecialist.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the number of glaucoma medications required to maintain target intraocular pressure (IOP) (time frame: 6 months post-DSLT treatment). 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 20 Apr 2026.