The Effects of an Antioxidant Formulation on Ocular Blood Flow
- Conditions
- Primary Open Angle Glaucoma
- Interventions
- Dietary Supplement: dietary supplement with antioxidantsDietary Supplement: Placebo
- Registration Number
- NCT01930487
- Lead Sponsor
- ScienceBased Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- 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.
- History of acute angle-closure or a narrow, occluding of anterior chamber angle by gonioscopy.
- History of chronic or recurrent inflammatory eye diseases or signs of intraocular trauma and/or unreliable applanation tonometry.
- Severe, unstable or uncontrolled cardiovascular, renal or pulmonary disease
- History of/or current renal or hepatic impairment.
- History of/or current bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiogenic shock.
- Recent surgery or surgery planned near study timeline
- History of bleeding disorder
- Use of blood thinning medications
- Use of specified dietary supplements for three weeks prior to study entry and throughout study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description supplement w/ antioxidants then placebo dietary supplement with antioxidants dietary supplement with antioxidants, followed by placebo supplement placebo then supplement w/ antioxidants dietary supplement with antioxidants placebo supplement, followed by dietary supplement with antioxidants placebo then supplement w/ antioxidants Placebo placebo supplement, followed by dietary supplement with antioxidants supplement w/ antioxidants then placebo Placebo dietary supplement with antioxidants, followed by placebo supplement
- Primary Outcome Measures
Name Time Method Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) 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) 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)
- Secondary Outcome Measures
Name Time Method Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) 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 Ocular Perfusion Pressure 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) 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 Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) 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) 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 Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) 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 Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM 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) - No DM 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 Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM 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 Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM 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 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) - No DM 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 Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) 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 Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM 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 Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM 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 Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM 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 Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM 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 Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM 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) 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 Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) 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 Blood Flow - Vascular Resistance (Ratio) 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 Peak Systolic Blood Flow Velocity (cm/s) - DM 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 Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM 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 Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM 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 Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM 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 Artery Blood Flow - Vascular Resistance (Ratio) - No DM 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 Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM 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
Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) 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) 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 Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio) 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 Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM 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 Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM 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 Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM 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 Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM 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 Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM 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 Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM 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 Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM 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 End Diastolic Blood Flow Velocity (cm/s) - DM 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 Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM 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 Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM 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 Ocular Perfusion Pressure - DM 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 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 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
Trial Locations
- Locations (1)
Glick Eye Institute, Ocular Vascular Research Center, Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States