Understanding retinal blood flow in glaucoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to establish retinal blood flow autoregulation as a biomarker for early primary open angle glaucoma (POAG). It focuses on the relationship between impaired retinal blood flow and the progression of glaucoma, utilizing advanced imaging techniques such as erythrocyte mediated angiography flowmetry and multimodal adaptive optics. By directly measuring retinal blood flow, the researchers hope to identify early signs of glaucoma that could lead to more effective interventions. The study will assess the extent of autoregulatory impairment and its predictive value for glaucoma damage.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Osamah Saeedi, MD, MS
• Email: osaeedi@som.umaryland.edu
• Phone: (410) 328-5929

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.