Change in Diurnal Intraocular Pressure Fluctuation Following Direct Selective Laser Trabeculoplasty
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.
∙ Visit 1 (Screening)
• Subject status as follows:
‣ 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 OAG (i.e., primary, pseudoexfoliation, or pigmentary glaucoma) of any severity or OHT in the study eye (i.e., eye to undergo surgery).
• IOP-lowering medication regimen in the study eye as follows:
• a. Zero to three topical IOP-lowering medication classes at the time of Visit 1 (Screening) exam (Note: fixed combination medications \[e.g., Cosopt®, Combigan®, Rocklatan®, Simbrinza®\] count as two medications).
• Angle anatomy in the study eye defined as follows:
‣ 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.
∙ Visit 2 (Baseline/Treatment)
• Medicated mean diurnal IOP (based on 8AM, 10AM and 4PM assessments) of ≥ 16 mmHg and less than or equal to 30 mmHg.
• Able and willing to attend scheduled follow-up exams for 6 months post-operatively.
• Successful DSLT treatment.