The Effects of an Antioxidant Formulation on Ocular Blood Flow

The Effects of an Antioxidant Formulation on Intraocular Pressure, Ocular Perfusion Pressure, Retrobulbar, Retinal Capillary and Choroidal Blood Flow

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 Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Dietary supplement: dietary supplement with antioxidants; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Glick Eye Institute, Ocular Vascular Research Center, Indiana University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: supplement w/ antioxidants then placebo; dietary supplement with antioxidants, followed by placebo supplement	Dietary supplement: dietary supplement with antioxidants; Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids; Other Names: Optic Nerve Formula; Dietary supplement: Placebo; Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants
Experimental: placebo then supplement w/ antioxidants; placebo supplement, followed by dietary supplement with antioxidants	Dietary supplement: dietary supplement with antioxidants; Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids; Other Names: Optic Nerve Formula; Dietary supplement: Placebo; Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	baseline and 30 days
Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)	change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)	baseline and 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ocular Perfusion Pressure	change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)	baseline and 30 days
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)	change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)	baseline and 30 days
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)	change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)	baseline and 30 days
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)	change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)	baseline and 30 days
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)	change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)	baseline and 30 days
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)	change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)	baseline and 30 days
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)	change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)	baseline and 30 days
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)	change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)	baseline and 30 days
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)	change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)	baseline and 30 days
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)	change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)	baseline and 30 days
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)	change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)	baseline and 30 days
Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)	change (post-treatment - pre-treatment) in nasal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)	baseline and 30 days
Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)	change (post-treatment - pre-treatment) in temporal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)	baseline and 30 days
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM	change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM	change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM	change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM	change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM	change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM	change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM	change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM	change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM	change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM	change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM	change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM	change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM	change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM	change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM	change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM	change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM	change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM	change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM	change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM	change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM	change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM	change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM	change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes	baseline and 30 days
Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM	change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes	baseline and 30 days
Change in Ocular Perfusion Pressure - DM	change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes	baseline and 30 days
Change in Ocular Perfusion Pressure - No DM	change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes	baseline and 30 days
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM	change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes	baseline and 30 days
Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM	change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes	baseline and 30 days
Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM	change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes	baseline and 30 days
Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM	change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes	baseline and 30 days

Collaborators and Investigators

• Sponsor: ScienceBased Health
• Investigators: Principal Investigator: Alon Harris, PhD, Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 9, 2013
• First Submitted That Met QC Criteria: August 23, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Estimate): December 5, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: intraocular pressure; retinal capillary blood flow; Primary open angle glaucoma; ocular perfusion pressure; choroidal blood flow; retrobulbar blood flow
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: 007