Actively Recruiting
Change in IOP Fluctuation After DSLT
Led by Ophthalmology Associates, Fort Worth · Updated on 2026-04-20
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
O
Ophthalmology Associates, Fort Worth
Lead Sponsor
S
Sengi
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, single-center, single-arm, observational study designed to evaluate the change in diurnal intraocular pressure (IOP) fluctuation following Direct Selective Laser Trabeculoplasty (DSLT) in patients with primary open-angle glaucoma (POAG) who are on 1-3 IOP lowering medications. The study will be conducted at one site and will involve three key visits: a screening visit, a baseline/treatment visit, and a 6-month follow-up visit. During the screening visit, patients will undergo a comprehensive ophthalmic examination, and eligibility will be confirmed. The eye with the higher IOP will be selected if both eyes are eligible. At the baseline visit, diurnal IOP will be recorded at three time points (9am, 12pm, and 4pm) before DSLT is performed. The primary endpoint is the change in diurnal IOP fluctuation 6 months post-treatment. Secondary endpoints include changes in mean diurnal IOP and the proportion of eyes achieving a reduction in IOP fluctuations of ≥1 mmHg. Exploratory endpoints focus on demographic variables associated with IOP fluctuation changes.
CONDITIONS
Official Title
Change in IOP Fluctuation After DSLT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years of age or older
- Able and willing to attend scheduled follow-up exams for 6 months post-operatively
- Able and willing to provide written informed consent on the IRB-approved Informed Consent Form
- Diagnosis of open-angle glaucoma (primary, pseudoexfoliation, or pigmentary) or ocular hypertension in the study eye
- Using zero to three topical IOP-lowering medication classes in the study eye at screening
- Trabecular meshwork visible on gonioscopy with Shaffer grade 3 or higher
- Normal angle anatomy without peripheral anterior synechia, rubeosis, or other angle abnormalities
- Medicated mean diurnal IOP between 16 mmHg and 30 mmHg at baseline
- Successful DSLT treatment
- Able and willing to attend scheduled follow-up exams for 6 months post-operatively
You will not qualify if you...
- Traumatic, malignant, uveitic, neovascular, or angle-closure glaucoma; glaucoma associated with vascular disorders
- Severe or significant visual field loss, including mean deviation worse than -20 dB
- Prior incisional glaucoma surgery, ALT, or minimally invasive glaucoma surgery
- History of iridotomy, SLT, or MicroPulse Laser Trabeculoplasty within 2 years
- Unable to provide adequate visual field exam results
- Vertical cup-to-disc ratio greater than 0.8 in the study eye
- Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome, or conditions causing elevated episcleral venous pressure
- Active corneal inflammation, endothelial dystrophy, prior corneal transplantation, or significant corneal scarring
- Visually significant cataract requiring surgery within 6 months or recent cataract surgery within 24 months
- Anterior chamber intraocular lens or implantable contact lens
- Congenital or traumatic cataract (except Mittendorf dots)
- Choroidal detachment, effusion, choroiditis, neovascularization, or active choroidopathy
- Retinal or optic nerve disorders not related to glaucoma, including proliferative diabetic retinopathy
- Clinically significant ocular trauma sequelae or chronic ocular inflammatory disease
- Prior glaucoma stent or intracameral implant or drug product
- Any condition risking or contraindicating study procedures or compliance
- Fellow eye vision worse than 20/200 or enrolled in other clinical trials
- Breast-feeding, pregnant, or planning pregnancy during the study
- Uncontrolled systemic disease or immunodeficiency
- Recent or anticipated use of steroids that may increase IOP (except nasal or topical dermal)
- Participation in another study within 30 days
- Recent or planned use of systemic acetazolamide or methazolamide
- Recent or planned changes in systemic therapy affecting IOP
- Any ocular disease or condition that may risk safety or study results
- Central corneal thickness greater than 620 microns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ophthalmology Associates
Fort Worth, Texas, United States, 76102
Actively Recruiting
Research Team
K
Kaitlin Sinclair
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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