Change in IOP Fluctuation After DSLT (NCT07428668) | Clinical Trial Compass
RecruitingNot Applicable
Change in IOP Fluctuation After DSLT
United States40 participantsStarted 2026-04-02
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Trabecular meshwork visible on gonioscopy defined by Shaffer grade ≥ 3.
✓. Normal anatomy as determined by gonioscopy.
✓. Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper DSLT treatment.
Exclusion criteria
✕. Traumatic, malignant, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders.
✕. Functionally significant visual field loss, including severe nerve fiber bundle defects.
✕. Visual field (mean deviation) worse than -20 dB using 24-2 SITA Standard or equivalent.
What they're measuring
1
Change in diurnal intraocular pressure (IOP) fluctuation
Timeframe: Measured at baseline and at 6 months post-DSLT treatment