The Effects of an Antioxidant Formulation on Ocular Blood Flow

N/ACompletedNCT01930487

ScienceBased Health47 enrolled

Overview

The objective is to evaluate the effects of an antioxidant formula versus placebo on ocular blood flow in a randomized double-blind, crossover design. Based upon preliminary data, it is hypothesized that a dietary supplement containing a variety of ingredients with antioxidant properties will, compared to placebo, increase ocular perfusion pressure, retrobulbar, retinal capillary and choroidal blood flow, and maintain these effects over the course of the treatment period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Primary Open Angle Glaucoma

Interventions

dietary supplement with antioxidantsDIETARY_SUPPLEMENT

Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

PlaceboDIETARY_SUPPLEMENT

Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 30 years or older. * Confirmed diagnosis of open angle glaucoma by glaucoma specialist in the study eye, as evidenced from criteria representative of glaucomatous optic nerve damage such as specific optic disc or retinal nerve fiber layer structural abnormalities and/or visual field abnormalities. * Best corrected visual acuity at 20/60 or better in study eye. * Willingness to avoid caffeine and smoking for 12 hours before and during the study visits. Exclusion Criteria: * History of acute angle-closure or a narrow, occluding of anterior chamber angle by gonioscopy. * History of chronic or recurrent inflammatory eye diseases or signs of intraocular trauma and/or unreliable applanation tonometry. * Severe, unstable or uncontrolled cardiovascular, renal or pulmonary disease * History of/or current renal or hepatic impairment. * History of/or current bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiogenic shock. * Recent surgery or surgery planned near study timeline * History of bleeding disorder * Use of blood thinning medications * Use of specified dietary supplements for three weeks prior to study entry and throughout study period.

Locations (1)

Glick Eye Institute, Ocular Vascular Research Center, Indiana University School of Medicine

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)

change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)