Status:
RECRUITING
Retinal Blood Flow and Autoregulation
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Glaucoma
Eligibility:
All Genders
18-88 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to establish autoregulation of retinal blood flow in arterioles and capillaries as a biomarker for early primary open angle glaucoma.
Detailed Description
There is strong evidence for a vascular component in the development and progression of primary open angle glaucoma (POAG). Specifically, glaucoma is associated with impaired retinal blood flow (RBF) ...
Eligibility Criteria
Inclusion
- age over 18 years
- open angle in gonioscopy (grade 3 or 4 in Shaffer classification)
- refractive error within the range of +3.00 to -8.00 diopters (4) best-corrected visual acuity 20/25 or better (5) Individuals recruited will be in one of the 3 groups:
- 1\) Early Glaucoma as per Hodapp-Anderson-Parrish Criteria (54). Early glaucoma subjects specifically with visual field defects restricted to one side of the horizontal midline will be selected to allow for comparison of rates of progression in both hemifields. Individuals will need to be off of glaucoma medications for four weeks to participate in the study. 2) Pre-perimetric glaucoma defined as the presence of glaucomatous optic nerve damage (e.g., focal notching, rim thinning), RNFL defect, and the absence of a definite glaucomatous visual field defect using standard automated perimetry at the three most recent consecutive examinations. A glaucomatous visual field defect is defined as either 3 or more abnormal points with a P\<0.05, of which at least 1 point has a pattern standard deviation (PSD) of P\<0.01; or a PSD of P\<0.05; or glaucoma hemifield test values outside the normal limits. (55,56) 3) Control group - A subject with no family history of glaucoma who has the following: a) OCT with all four quadrants within the normal range for age-matched controls, b) reliable visual fields with glaucoma hemifield test within normal limits and determined to be normal by a glaucoma specialist, and c) cup-to-disc ratio of 0.4 or lower and asymmetry of the cup to disc ratio no greater than 0.1 as determined by a glaucoma specialist.
- Control subjects will be age matched to the early glaucoma subjects.
Exclusion
- corneal abnormalities or other conditions preventing reliable applanation tonometry
- retinal disease affecting retinal nerve fiber layer thickness such as vitreomacular traction as determined by a glaucoma specialist
- secondary glaucoma
- history of prior ocular surgery other than uncomplicated cataract surgery or laser trabeculoplasty
- inability to safely be off of glaucoma medications for 4 weeks
- inability to obtain OCT angiography data due to excessive eye motion or inability to fixate
- unreliable visual fields
- any history of smoking in the past 6 months
- cataract greater than lens opacity classification system (LOCS) II Grade≥2
- diagnosis of diabetes, hypertension, or other known vascular disorder such as vasculitis
Key Trial Info
Start Date :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05344274
Start Date
May 23 2022
End Date
September 1 2027
Last Update
December 2 2025
Active Locations (4)
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1
University of Maryland Faculty Physicians, Inc
Baltimore, Maryland, United States, 21201
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
3
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
4
Food and Drug Administration (FDA)
Silver Spring, Maryland, United States, 20903