Recruiting
Retinal Blood Flow and Autoregulation
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.
ClinicalTrials.gov IDNCT05344274
PhasePHASE4
Enrollment90
SponsorUniversity of Maryland, Baltimore
Age18 Years
SexALL
Conditions studied
Glaucoma
About this study
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.
Interventions
- Diagnostic Test: Indocyanine Green Angiography — Erythrocyte Mediated Angiography with indocyanine green as well as conventional indocyanine green angiography will be conducted to determine retinal blood flow
- Biological: Isocapnic Oxygen — Investigators will evaluate retinal blood flow (RBF) in response to oxygen supplementation at a constant level of carbon dioxide (isocapnic hyperoxia) to isolate the vascular autoregulatory response to oxygen.
- Diagnostic Test: Ocular Imaging with Optical Coherence Tomography (OCT) and Adaptive Optics (AO) — Investigators will image subjects with OCT as well as AO technology to determine retinal ganglion cell density, vessel density, and vessel flowrates
Primary outcomes
- Autoregulation of retinal blood flow (3 years)
Eligibility information
Inclusion Criteria:
1. age over 18 years
2. open angle in gonioscopy (grade 3 or 4 in Shaffer classification)
3. 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 Criteria:
1. corneal abnormalities or other conditions preventing reliable applanation tonometry
2. retinal disease affecting retinal nerve fiber layer thickness such as vitreomacular traction as determined by a glaucoma specialist
3. secondary glaucoma
4. history of prior ocular surgery other than uncomplicated cataract surgery or laser trabeculoplasty
5. inability to safely be off of glaucoma medications for 4 weeks
6. inability to obtain OCT angiography data due to excessive eye motion or inability to fixate
7. unreliable visual fields
8. any history of smoking in the past 6 months
9. cataract greater than lens opacity classification system (LOCS) II Grade≥2
10. diagnosis of diabetes, hypertension, or other known vascular disorder such as vasculitis
Study locations
- University of Maryland Faculty Physicians, Inc, Baltimore, Maryland 21201 United States
- University of Maryland Medical Center, Baltimore, Maryland 21201 United States
- University of Maryland, Baltimore, Baltimore, Maryland 21201 United States
- Food and Drug Administration (FDA), Silver Spring, Maryland 20903 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.