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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| supplement w/ antioxidants then placebo | Experimental | dietary supplement with antioxidants, followed by placebo supplement |
|
| placebo then supplement w/ antioxidants | Experimental | placebo supplement, followed by dietary supplement with antioxidants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary supplement with antioxidants | Dietary Supplement | Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alon Harris, PhD | Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glick Eye Institute, Ocular Vascular Research Center, Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
1 subject started but did not complete the baseline examination and was not randomized to either treatment arm.
47 patients were recruited for the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Supplement With Antioxidants, Then Placebo | dietary supplement with antioxidants in the first intervention period, followed by placebo supplement in the second intervention period |
| FG001 | Placebo, Then Supplement With Antioxidants | placebo supplement in the second intervention period, followed by dietary supplement with antioxidants in the second intervention period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (30 Days) |
| |||||||||||||
| Washout Period (3 Weeks) |
| |||||||||||||
| Second Intervention (30 Days) |
|
patients who completed both periods of the crossover study
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Completing Study | Participants who completed both arms of the crossover study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | patients completing both study periods | Posted | Mean | Standard Error | % zero pixels | baseline and 30 days |
|
Four weeks for each intervention, with a 3-week wash out period between interventions
Safety population included all participants who completed study. (45 patients with OAG were enrolled, 42 of which were followed through to completion of the study. Three patients discontinued study participation due to difficulty in adhering to study visit timeline.)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supplement w/ Antioxidants | dietary supplement with antioxidants dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brent Siesky, PhD, Assistant Director | Ocular Vascular Research Center, Indiana University School of Medicine | 317-278-0177 | bsiesky@indiana.edu |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D000975 | Antioxidants |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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|
| Placebo | Dietary Supplement | Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants |
|
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 |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Diabetes (Type 2) | Number | participants |
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| Hypertension | Number | participants |
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| Study Eye | Number | participants |
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| Duration of OAG | Mean | Standard Deviation | years |
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Placebo identical in appearance to active
Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants
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|
| Primary | 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) | patients completing both study periods | Posted | Mean | Standard Error | % zero pixels | baseline and 30 days |
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| Secondary | Change in Ocular Perfusion Pressure | change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure) | patients completing both study periods | Posted | Mean | Standard Error | mm Hg | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | 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) | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | cm/s | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | ratio | baseline and 30 days |
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| Secondary | Change in Ocular Perfusion Pressure - DM | change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes | patients completing both study periods | Posted | Mean | Standard Error | mm Hg | baseline and 30 days |
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| Secondary | Change in Ocular Perfusion Pressure - No DM | change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes | patients completing both study periods | Posted | Mean | Standard Error | mm Hg | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | % zero pixels | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | % zero pixels | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | % zero pixels | baseline and 30 days |
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| Secondary | 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 | patients completing both study periods | Posted | Mean | Standard Error | % zero pixels | baseline and 30 days |
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| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Placebo | placebo supplement Placebo: Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants | 0 | 21 | 0 | 21 |
Not provided
Not provided
| D001685 |
| Biological Factors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020313 | Specialty Uses of Chemicals |