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Clinical Trials/NCT07281391
NCT07281391RecruitingNot Applicable

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

Mann Eye Institute1 site in 1 country45 target enrollmentStarted: March 19, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
45
Locations
1
Primary Endpoint
Mean washed-out IOP change post-DSLT compared to washed-out baseline IOP

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: 6 months post-DSLT

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(6 months post-DSLT)
  • Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications(6 months post-DSLT)
  • Change in number of glaucoma medication(s)(6 months post-DSLT)
  • Proportion of medication free eyes post-DSLT(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(12 months post-DSLT)
  • Qualified success: proportion of eyes with IOP reduction (15-20%) without increase in baseline glaucoma medications(12 months post-DSLT)
  • Change in number of glaucoma medication(s)(12 months post-DSLT)
  • Proportion of medication free eyes post-DSLT(12 months post-DSLT)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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