Back to results

The Effects of an Antioxidant Formulation on Ocular Blood Flow

Primary Purpose

Primary Open Angle Glaucoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

dietary supplement with antioxidants

Placebo

About this trial

This is an interventional basic science trial for Primary Open Angle Glaucoma focused on measuring Primary open angle glaucoma, intraocular pressure, ocular perfusion pressure, retrobulbar blood flow, retinal capillary blood flow, choroidal blood flow

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

supplement w/ antioxidants then placebo

placebo then supplement w/ antioxidants

Arm Description

dietary supplement with antioxidants, followed by placebo supplement

placebo supplement, followed by dietary supplement with antioxidants

Outcomes

Primary Outcome Measures

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)

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)

Secondary Outcome Measures

Change in Ocular Perfusion Pressure

change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Change in Ocular Perfusion Pressure - DM

change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes

Change in Ocular Perfusion Pressure - No DM

change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes

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

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

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

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

Full Information

NCT ID

NCT01930487

First Posted

August 9, 2013

Last Updated

October 13, 2016

Sponsor

ScienceBased Health

1. Study Identification

Unique Protocol Identification Number

NCT01930487

Brief Title

The Effects of an Antioxidant Formulation on Ocular Blood Flow

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ScienceBased Health

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open Angle Glaucoma

Keywords

Primary open angle glaucoma, intraocular pressure, ocular perfusion pressure, retrobulbar blood flow, retinal capillary blood flow, choroidal blood flow

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

supplement w/ antioxidants then placebo

Arm Type

Experimental

Arm Description

dietary supplement with antioxidants, followed by placebo supplement

Arm Title

placebo then supplement w/ antioxidants

Arm Type

Experimental

Arm Description

placebo supplement, followed by dietary supplement with antioxidants

Intervention Type

Dietary Supplement

Intervention Name(s)

dietary supplement with antioxidants

Other Intervention Name(s)

Optic Nerve Formula

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

baseline and 30 days

Title

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

Description

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

Time Frame

baseline and 30 days

Secondary Outcome Measure Information:

Title

Change in Ocular Perfusion Pressure

Description

change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)

Time Frame

baseline and 30 days

Title

Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)

Description

change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)

Description

change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)

Description

change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)

Description

change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)

Description

change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)

Description

change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)

Description

change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)

Description

change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)

Description

change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)

Description

change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)

Description

change (post-treatment - pre-treatment) in nasal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)

Description

change (post-treatment - pre-treatment) in temporal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

Time Frame

baseline and 30 days

Title

Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM

Description

change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes

Time Frame

baseline and 30 days

Title

Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM

Description

change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes

Time Frame

baseline and 30 days

Title

Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Ocular Perfusion Pressure - DM

Description

change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes

Time Frame

baseline and 30 days

Title

Change in Ocular Perfusion Pressure - No DM

Description

change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes

Time Frame

baseline and 30 days

Title

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

Description

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

Time Frame

baseline and 30 days

Title

Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM

Description

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

Time Frame

baseline and 30 days

Title

Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM

Description

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

Time Frame

baseline and 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alon Harris, PhD

Organizational Affiliation

Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of an Antioxidant Formulation on Ocular Blood Flow

We'll reach out to this number within 24 hrs