NCT07281391RecruitingNot Applicable
Direct Selective Laser Trabeculoplasty Providing Effective Intraocular Pressure Reduction in Pigmentary Glaucoma Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mann Eye Institute
- 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
Study Sites (1)
Loading locations...
Similar Trials
Withdrawn
Not Applicable
Direct Selective Laser Trabeculoplasty in Ethnic Chinese Population The Zhuiguang TrialGlaucoma, Open-AngleOcular HypertensionNCT05043831BelkinVision
Active, not recruiting
Phase 1
aser treatment versus eye drops as initial treatment in exfoliation glaucomaEUCTR2019-004841-34-FIMika Harju112
Completed
Not Applicable
Selective Laser Trabeculoplasty Efficacy in Patients with Primary Angle Closure Glaucoma after Iridotomy and Primary Open Angle GlaucomaIntraocular pressureSelective laser trabeculoplasty efficacyTCTR20150126001one75
Completed
Not Applicable
Selective laser trabeculoplasty (SLT) for the primary treatment of primary open angle glaucoma and ocular hypertensioEye Diseases: GlaucomaEye DiseasesGlaucomaISRCTN77145641Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)40
Completed
Not Applicable
A study to assess an automated laser device to treat glaucomaISRCTN14033075BELKIN Laser Ltd276