The Effects of an Antioxidant Formulation on Ocular Blood Flow

Study Overview
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Brief Summary
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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.

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

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Dietary Supplement: dietary supplement with antioxidants
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary open angle glaucoma, intraocular pressure, ocular perfusion pressure, retrobulbar blood flow, retinal capillary blood flow, choroidal blood flow