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NCT05344274RecruitingPhase 4

Retinal Blood Flow and Autoregulation

Direct Measures of Retinal Blood Flow and Autoregulation as Robust Biomarkers for Early Glaucoma

Source: ClinicalTrials.gov · Last updated 2 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
90 (estimated)
First submitted
18 Apr 2022
Start date
23 May 2022
Primary completion date
Sept 2027
Lead sponsor
University of Maryland, Baltimore
Diseases
Glaucoma
NCT number
NCT05344274

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 90
  • From 23 May 2022 to the primary completion date, Sept 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • history of prior ocular surgery other than uncomplicated cataract surgery or laser trabeculoplasty
  • inability to safely be off of glaucoma medications for 4 weeks

Other illness

  • 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
  • any history of smoking in the past 6 months
  • diagnosis of diabetes, hypertension, or other known vascular disorder such as vasculitis

Other

  • secondary glaucoma
  • inability to obtain OCT angiography data due to excessive eye motion or inability to fixate
  • unreliable visual fields
  • cataract greater than lens opacity classification system (LOCS) II Grade≥2

Who the study is looking for

  • 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.

Age in the registry: 18 years to 88 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Maryland, Baltimore
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
University of Maryland Medical Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
University of Maryland Faculty Physicians, Inc
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Food and Drug Administration (FDA)
Coordinator of this site? Confirm its status
Silver SpringUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.