Primary Open Angle Glaucoma
Conditions
Keywords
Primary open angle glaucoma, intraocular pressure, ocular perfusion pressure, retrobulbar blood flow, retinal capillary blood flow, choroidal blood flow
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.
Interventions
DIETARY_SUPPLEMENTdietary supplement with antioxidants
Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids
DIETARY_SUPPLEMENTPlacebo
Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants
Sponsors
ScienceBased Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 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 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 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 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 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 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 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) - 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) - 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 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 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 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 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 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 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 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 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 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 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 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 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) - 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 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 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 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 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 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 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 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 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 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 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 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 |
| 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) |
Countries
United States
Participant flow
Recruitment details
47 patients were recruited for the study
Pre-assignment details
1 subject started but did not complete the baseline examination and was not randomized to either treatment arm.
Participants by arm
| Arm | Count |
|---|---|
| Participants Completing Study Participants who completed both arms of the crossover study | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Participants Completing Study |
|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 11 |
| Diabetes (Type 2) no | 21 participants |
| Diabetes (Type 2) yes | 21 participants |
| Duration of OAG | 15 years STANDARD_DEVIATION 8 |
| Hypertension no | 26 participants |
| Hypertension yes | 16 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 18 Participants |
| Study Eye left | 18 participants |
| Study Eye right | 24 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) | -0.016 % zero pixels | Standard Error 0.007 |
| Placebo | Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) | 0.009 % zero pixels | Standard Error 0.007 |
p-value: 0.0249paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) | -0.026 % zero pixels | Standard Error 0.008 |
| Placebo | Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) | 0.011 % zero pixels | Standard Error 0.007 |
p-value: 0.0016paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) | -0.018 ratio | Standard Error 0.006 |
| Placebo | Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) | 0.000 ratio | Standard Error 0.006 |
p-value: 0.0482paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM | -0.019 ratio | Standard Error 0.01 |
| Placebo | Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM | -0.004 ratio | Standard Error 0.011 |
p-value: 0.3414paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM | -0.017 ratio | Standard Error 0.007 |
| Placebo | Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM | 0.004 ratio | Standard Error 0.007 |
p-value: 0.033paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) | 0.27 cm/s | Standard Error 0.05 |
| Placebo | Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) | -0.11 cm/s | Standard Error 0.06 |
p-value: <0.0001paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM | 0.29 cm/s | Standard Error 0.06 |
| Placebo | Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM | -0.08 cm/s | Standard Error 0.11 |
p-value: 0.0119paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM | 0.26 cm/s | Standard Error 0.07 |
| Placebo | Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM | -0.14 cm/s | Standard Error 0.07 |
p-value: <0.0001paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) | 0.54 cm/s | Standard Error 0.15 |
| Placebo | Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) | -0.43 cm/s | Standard Error 0.15 |
p-value: <0.0001paired t-test, 2-sidede
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM | 0.58 cm/s | Standard Error 0.2 |
| Placebo | Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM | -0.44 cm/s | Standard Error 0.24 |
p-value: 0.0094paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM | 0.51 cm/s | Standard Error 0.23 |
| Placebo | Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM | -0.41 cm/s | Standard Error 0.2 |
p-value: 0.0009paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM | -0.005 % zero pixels | Standard Error 0.009 |
| Placebo | Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM | 0.000 % zero pixels | Standard Error 0.008 |
p-value: 0.6941paired t-test
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM | -0.028 % zero pixels | Standard Error 0.009 |
| Placebo | Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM | 0.018 % zero pixels | Standard Error 0.01 |
p-value: 0.0138paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM | -0.005 ratio | Standard Error 0.007 |
| Placebo | Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM | 0.005 ratio | Standard Error 0.007 |
p-value: 0.3326paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM | -0.022 ratio | Standard Error 0.01 |
| Placebo | Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM | 0.005 ratio | Standard Error 0.007 |
p-value: 0.0348paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio) | -0.013 ratio | Standard Error 0.006 |
| Placebo | Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio) | 0.005 ratio | Standard Error 0.005 |
p-value: 0.023paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) | 0.17 cm/s | Standard Error 0.05 |
| Placebo | Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) | -0.07 cm/s | Standard Error 0.05 |
p-value: 0.0024paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM | 0.16 cm/s | Standard Error 0.07 |
| Placebo | Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM | -0.16 cm/s | Standard Error 0.08 |
p-value: 0.0137paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM | 0.18 cm/s | Standard Error 0.07 |
| Placebo | Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM | 0.01 cm/s | Standard Error 0.07 |
p-value: 0.0866paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) | 0.30 cm/s | Standard Error 0.14 |
| Placebo | Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) | -0.16 cm/s | Standard Error 0.16 |
p-value: 0.0476paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM | 0.56 cm/s | Standard Error 0.22 |
| Placebo | Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM | -0.46 cm/s | Standard Error 0.23 |
p-value: 0.0067paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM | 0.03 cm/s | Standard Error 0.16 |
| Placebo | Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM | 0.13 cm/s | Standard Error 0.22 |
p-value: 0.6938paired t-test, 2-sided
Secondary
Change in Ocular Perfusion Pressure
change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ocular Perfusion Pressure | 1.5 mm Hg | Standard Error 0.9 |
| Placebo | Change in Ocular Perfusion Pressure | 1.4 mm Hg | Standard Error 1.2 |
p-value: 0.9147paired t-test, 2-sided
Secondary
Change in Ocular Perfusion Pressure - DM
change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ocular Perfusion Pressure - DM | 0.2 mm Hg | Standard Error 1.2 |
| Placebo | Change in Ocular Perfusion Pressure - DM | -1.1 mm Hg | Standard Error 1.4 |
p-value: 0.447paired t-test, 2-sided
Secondary
Change in Ocular Perfusion Pressure - No DM
change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ocular Perfusion Pressure - No DM | 2.8 mm Hg | Standard Error 1.4 |
| Placebo | Change in Ocular Perfusion Pressure - No DM | 3.8 mm Hg | Standard Error 1.7 |
p-value: 0.6382paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) | -0.007 ratio | Standard Error 0.004 |
| Placebo | Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) | -0.005 ratio | Standard Error 0.006 |
p-value: 0.8191paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM | -0.008 ratio | Standard Error 0.007 |
| Placebo | Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM | -0.005 ratio | Standard Error 0.009 |
p-value: 0.81paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM | -0.005 ratio | Standard Error 0.006 |
| Placebo | Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM | -0.004 ratio | Standard Error 0.009 |
p-value: 0.9556paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) | 0.35 cm/s | Standard Error 0.13 |
| Placebo | Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) | -0.17 cm/s | Standard Error 0.17 |
p-value: 0.0208paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM | 0.60 cm/s | Standard Error 0.19 |
| Placebo | Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM | -0.18 cm/s | Standard Error 0.24 |
p-value: 0.0323paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM | 0.09 cm/s | Standard Error 0.18 |
| Placebo | Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM | -0.16 cm/s | Standard Error 0.24 |
p-value: 0.344paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) | 0.74 cm/s | Standard Error 0.41 |
| Placebo | Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) | -0.94 cm/s | Standard Error 0.38 |
p-value: 0.007paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM | 1.71 cm/s | Standard Error 0.56 |
| Placebo | Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM | -0.84 cm/s | Standard Error 0.48 |
p-value: 0.0063paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM | -0.24 cm/s | Standard Error 0.53 |
| Placebo | Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM | -1.03 cm/s | Standard Error 0.6 |
p-value: 0.3347paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM | -0.031 % zero pixels | Standard Error 0.009 |
| Placebo | Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM | 0.012 % zero pixels | Standard Error 0.01 |
p-value: 0.0026paird t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM | -0.021 % zero pixels | Standard Error 0.014 |
| Placebo | Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM | 0.010 % zero pixels | Standard Error 0.009 |
p-value: 0.1045paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM | -0.006 ratio | Standard Error 0.009 |
| Placebo | Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM | 0.010 ratio | Standard Error 0.007 |
p-value: 0.2089paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM | -0.012 ratio | Standard Error 0.009 |
| Placebo | Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM | -0.001 ratio | Standard Error 0.007 |
p-value: 0.3738paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio) | -0.009 ratio | Standard Error 0.006 |
| Placebo | Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio) | 0.004 ratio | Standard Error 0.005 |
p-value: 0.1202paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) | 0.15 cm/s | Standard Error 0.05 |
| Placebo | Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) | -0.06 cm/s | Standard Error 0.05 |
p-value: 0.0081paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM | 0.10 cm/s | Standard Error 0.07 |
| Placebo | Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM | -0.13 cm/s | Standard Error 0.07 |
p-value: 0.0656paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM | 0.20 cm/s | Standard Error 0.08 |
| Placebo | Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM | 0.01 cm/s | Standard Error 0.08 |
p-value: 0.0626paired t-test, 2-sided
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)
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) | 0.31 cm/s | Standard Error 0.16 |
| Placebo | Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) | -0.14 cm/s | Standard Error 0.15 |
p-value: 0.0352paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM | 0.24 cm/s | Standard Error 0.19 |
| Placebo | Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM | -0.32 cm/s | Standard Error 0.21 |
p-value: 0.0805paired t-test, 2-sided
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
Time frame: baseline and 30 days
Population: patients completing both study periods
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietary Supplement With Antioxidants | Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM | 0.38 cm/s | Standard Error 0.27 |
| Placebo | Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM | 0.03 cm/s | Standard Error 0.21 |
p-value: 0.2451paired t-test, 2-sided