Pigmentary Dispersion SyndromeNCT07281391
IOP Reduction in Pigmentary Glaucoma Using DSLT
An observational study of Pigmentary Dispersion Syndrome and Pigmentary Dispersion Glaucoma, run by Mann Eye Institute at 1 site in United States.
Trial summary
This study is a single-site, single-arm, prospective, observational study of IOP reduction after DSLT. Subjects will be assessed up to 12 months post-operatively. Clinical evaluations will include IOP and number of glaucoma medications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pigmentary Dispersion Syndrome, Pigmentary Dispersion Glaucoma
- What is being tested?
- Voyager DSLT
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2026to 1 Apr 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: Eligible test subjects will be adult patients with pigmentary dispersion syndrome with elevated IOP or mild to moderate (based on AAO Preferred Practice Program criteria) pigmentary glaucoma with glaucomatous optic neuropathy and corresponding visual field/RNFL loss.
Who may be able to join
- Adult patients with pigmentary dispersion syndrome with elevated IOP or mild to moderate (based on AAO Preferred Practice Program criteria) pigmentary glaucoma with glaucomatous optic neuropathy and corresponding visual field/RNFL loss.
- Treatment naive, or washed out IOP ranging from ≥18-34 mmHg
- Central corneal thickness (CCT) 480-600 µm
- Able to complete medication washout and follow-up
Who cannot join
- Prior incisional glaucoma surgery or glaucoma-related procedures in the study eye
- Prior laser trabeculoplasty <3 years
- Prior intraocular surgery and refractive surgery, except for cataract surgery unless greater than 2 years
- Patients anticipating cataract surgery within the follow-up period
- History of ocular inflammation and infection
- All other secondary glaucoma including exfoliative
- Patients unable to have DSLT treatment
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
Mann Eye Institute
Houston, Texas, 76134-2099
Melissa Hamann Wright, 713-580-2500 ext. 2389, Melissa.Wright@manneye.com
Alex Hacopian, MD
About this study
Official title: Direct Selective Laser Trabeculoplasty Providing Effective Intraocular Pressure Reduction in Pigmentary Glaucoma Patients
This study is a single-site, single-arm, prospective, observational study of IOP reduction after DSLT. Subjects will be assessed up to 12 months post-operatively. Clinical evaluations will include IOP and number of glaucoma medications.
- Being tested
- Voyager DSLT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voyager DSLTDevice
DSLT is an innovative adaptation of traditional SLT. Rather than using a gonioscopic lens, DSLT applies laser energy directly through the limbus to the trabecular meshwork in a few seconds.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP
Measured: 6 months post-DSLT
Secondary outcomes (8)
Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP
Measured: 6 months post-DSLT
Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP
Measured: 12 months post-DSLT
Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications
Measured: 6 months post-DSLT
Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications
Measured: 12 months post-DSLT
Change in number of glaucoma medication(s)
This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT
Measured: 6 months post-DSLT
Change in number of glaucoma medication(s)
This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT
Measured: 12 months post-DSLT
Proportion of medication free eyes post-DSLT
This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT
Measured: 6 months post-DSLT
Proportion of medication free eyes post-DSLT
This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT
Measured: 12 months post-DSLT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start19 Mar 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmentary Dispersion SyndromeStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mann Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Alex Hacopian, MD, Principal investigator, Mann Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281391
- Sponsor's protocol ID
- AH-25-01
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Selective Laser Trabeculoplasty Providing Effective Intraocular Pressure Reduction in Pigmentary Glaucoma Patients
- ClinicalTrials.gov ID
- NCT07281391
- Acronym / sponsor ID
- AH-25-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mann Eye InstituteUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 15 Dec 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 is a single-site, single-arm, prospective, observational study of IOP reduction after DSLT. Subjects will be assessed up to 12 months post-operatively. Clinical evaluations will include IOP and number of glaucoma medications.
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
- Eligible test subjects will be adult patients with pigmentary dispersion syndrome with elevated IOP or mild to moderate (based on AAO Preferred Practice Program criteria) pigmentary glaucoma with glaucomatous optic neuropathy and corresponding visual field/RNFL loss.
Key inclusion criteria (4 listed)
- Adult patients with pigmentary dispersion syndrome with elevated IOP or mild to moderate (based on AAO Preferred Practice Program criteria) pigmentary glaucoma with glaucomatous optic neuropathy and corresponding visual field/RNFL loss.
- Treatment naive, or washed out IOP ranging from ≥18-34 mmHg
- Central corneal thickness (CCT) 480-600 µm
- Able to complete medication washout and follow-up
Key exclusion criteria (7 listed)
- Prior incisional glaucoma surgery or glaucoma-related procedures in the study eye
- Prior laser trabeculoplasty <3 years
- Prior intraocular surgery and refractive surgery, except for cataract surgery unless greater than 2 years
- Patients anticipating cataract surgery within the follow-up period
- History of ocular inflammation and infection
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 DSLTDSLT is an innovative adaptation of traditional SLT. Rather than using a gonioscopic lens, DSLT applies laser energy directly through the limbus to the trabecular meshwork in a few seconds. | Device | – |
Primary outcome
Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP
Time frame: 6 months post-DSLT
8 secondary outcomes
Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP
Time frame: 6 months post-DSLT
Complete success: proportion of eyes with ≥ 20% washed out IOP reduction post-DSLT without secondary interventions (additional medications or procedures) compared with washed out baseline IOP
Time frame: 12 months post-DSLT
Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications
Time frame: 6 months post-DSLT
Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications
Time frame: 12 months post-DSLT
Change in number of glaucoma medication(s)
Time frame: 6 months post-DSLT
Change in number of glaucoma medication(s)
Time frame: 12 months post-DSLT
Proportion of medication free eyes post-DSLT
Time frame: 6 months post-DSLT
Proportion of medication free eyes post-DSLT
Time frame: 12 months post-DSLT
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 9 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Pigmentary Dispersion Syndrome
Recruiting
XEN Glaucoma Gel Stent Versus Trabeculectomy
Primary Open Angle Glaucoma, Pseudoexfoliation 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.
Alex Hacopian, MD principal investigator
Mann Eye Institute
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 Pigmentary Dispersion Syndrome and Pigmentary Dispersion Glaucoma, run by Mann Eye Institute 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 4 inclusion and 7 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 9 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 Melissa Wright (713-580-2500, Melissa.Wright@manneye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP (time frame: 6 months post-DSLT). 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 9 Apr 2026.