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The Effects of an Antioxidant Formulation on Ocular Blood Flow

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01930487
First Posted: August 29, 2013
Last Update Posted: December 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ScienceBased Health
August 9, 2013
August 29, 2013
May 31, 2016
December 5, 2016
December 5, 2016
August 2013
July 2015   (Final data collection date for primary outcome measure)
  • Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)
  • retinal capillary blood flow [ Time Frame: 30 days ]
    retinal capillary blood flow in arbitrary units.
  • Retrobulbar blood flow velocities and vascular resistance [ Time Frame: 30 days ]
    Central retinal artery, ophthalmic artery, and temporal and nasal short posterior artery: peak systolic and end diastolic blood flow velocities (cm/s) and vascular resistance (ratio).
Complete list of historical versions of study NCT01930487 on ClinicalTrials.gov Archive Site
  • Change in Ocular Perfusion Pressure [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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) [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes
  • Change in Ocular Perfusion Pressure - No DM [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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 [ Time Frame: baseline and 30 days ]
    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
  • Ocular perfusion pressure [ Time Frame: 30 days ]
    2/3 Mean arterial pressure - intraocular pressure
  • Ocular pulse amplitude [ Time Frame: 30 days ]
    an measure used to estimate choroid blood flow in bulk
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Primary Open Angle Glaucoma
  • Dietary Supplement: dietary supplement with antioxidants
    Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids
    Other Name: Optic Nerve Formula
  • Dietary Supplement: Placebo
    Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants
  • Experimental: supplement w/ antioxidants then placebo
    dietary supplement with antioxidants, followed by placebo supplement
    Interventions:
    • Dietary Supplement: dietary supplement with antioxidants
    • Dietary Supplement: Placebo
  • Experimental: placebo then supplement w/ antioxidants
    placebo supplement, followed by dietary supplement with antioxidants
    Interventions:
    • Dietary Supplement: dietary supplement with antioxidants
    • Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
August 2015
July 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01930487
007
No
Not Provided
Not Provided
ScienceBased Health
ScienceBased Health
Not Provided
Principal Investigator: Alon Harris, PhD Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center
ScienceBased Health
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP