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Taking people in United StatesPhase 4

Measuring Eye Blood Flow to Study Early Glaucoma

Tests eye imaging methods to measure blood flow in people with early glaucoma.

Plain-language title generated from the registry record
Registry title: Retinal Blood Flow and Autoregulation

Key facts

Where
Baltimore and Silver Spring, United StatesSee the 4 sites
Phase
Phase 4

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 88 years old?

Source: NCT05344274, who can take part

Where in United States

  • University of Maryland Faculty Physicians, IncBaltimore, United StatesTaking people
  • University of Maryland Medical CenterBaltimore, United StatesTaking people
  • University of Maryland, BaltimoreBaltimore, United StatesTaking people
  • Food and Drug Administration (FDA)Silver Spring, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
University of Maryland, Baltimore
Trial code
NCT05344274
Record updated
2 December 2025
Original description
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.Read full original descriptionShow less

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

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.

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

ClinicalTrials.gov NCT05344274