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NCT Number: NCT07281391

IOP Reduction in Pigmentary Glaucoma Using DSLT

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.

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Key information

Conditions

Pigmentary Dispersion Syndrome Pigmentary Dispersion Glaucoma

Sex eligibility

All sexes

Study type

Observational

Primary location

Mann Eye Institute

Houston, Texas, 76134-2099, United States

Location status: Recruiting

Location contact

Alex Hacopian, MD

PRINCIPAL_INVESTIGATOR

Melissa Hamann Wright

CONTACT

[email protected]

713-580-2500 ext. 2389

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Voyager DSLT

Device

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.

Primary outcomes

  1. Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP

    Time frame: 6 months post-DSLT

Secondary outcomes

  1. 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

  2. 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

  3. Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications

    Time frame: 6 months post-DSLT

  4. Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications

    Time frame: 12 months post-DSLT

  5. Change in number of glaucoma medication(s)

    Time frame: 6 months post-DSLT

    This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT

  6. Change in number of glaucoma medication(s)

    Time frame: 12 months post-DSLT

    This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT

  7. Proportion of medication free eyes post-DSLT

    Time frame: 6 months post-DSLT

    This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT

  8. Proportion of medication free eyes post-DSLT

    Time frame: 12 months post-DSLT

    This applies to enrolled eyes already on medications, or to treatment-naive eyes experiencing an increase in medications after DSLT

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Wright

CONTACT

[email protected]

713-580-2500

Sponsors and collaborators

Lead sponsor

Mann Eye Institute

Other

Collaborators

  • Sengi

Registry information

Official study title

Direct Selective Laser Trabeculoplasty Providing Effective Intraocular Pressure Reduction in Pigmentary Glaucoma Patients

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 15, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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