Retinal Blood Flow and Autoregulation

Recruiting now · Phase 4

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT05344274

Run by

University of Maryland, Baltimore

People needed

90

Starts

2022-05-23

Expected to finish

2027-09-01

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older, up to 88. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• 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.

You may not qualify if…

• 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

Where it is running

• University of Maryland Faculty Physicians, Inc — Baltimore, Maryland, United States (enrolling)
• University of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)
• University of Maryland, Baltimore — Baltimore, Maryland, United States (enrolling)
• Food and Drug Administration (FDA) — Silver Spring, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.