- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07390890
DSLT for Reducing Medication in Glaucoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Renee Bondurant
- Phone Number: 727-450-4668
- Email: Renee.Bondurant@eyespecialist.com
Study Locations
-
-
Florida
-
Largo, Florida, United States, 33770
- Recruiting
- The Eye Institute of West Florida
-
Contact:
- Renee Bondurant
- Phone Number: 727-450-4668
- Email: Renee.Bondurant@eyespecialist.com
-
Principal Investigator:
- Neel Desai, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months post-DSLT treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in intraocular pressure (IOP) from baseline
Time Frame: 6 months post-DSLT treatment
|
IOP will be measured using Goldmann applanation tonometry at each follow-up visit.
|
6 months post-DSLT treatment
|
|
Proportion of eyes needing medication stratified by number of IOP medications required
Time Frame: 6 months post-DSLT treatment
|
6 months post-DSLT treatment
|
|
|
Number and type of Secondary surgical interventions
Time Frame: 6 months post-DSLT treatment
|
6 months post-DSLT treatment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Neel Desai, MD, The Eye Institute of West Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ND-25-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.