Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:34 AM
Study NCT ID:
NCT07428668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change in IOP Fluctuation After DSLT
Sponsor:
Ophthalmology Associates, Fort Worth
Organization:
Study Overview
Official Title:
Change in Diurnal Intraocular Pressure Fluctuation Following Direct Selective Laser Trabeculoplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: