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RECRUITINGPhase 4INTERVENTIONAL

Retinal Blood Flow and Autoregulation

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

Locations (4)

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