N/A
N=46
The Effects of an Antioxidant Formulation on Ocular Blood Flow
Primary Open Angle Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01930487 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) — -0.026; 0.011 % zero pixels — p=0.0016
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- dietary supplement with antioxidants (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- ScienceBased Health
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) |
-0.026; 0.011 | 0.0016 sig |
| PRIMARY Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) |
-0.016; 0.009 | 0.0249 sig |
| SECONDARY Change in Ocular Perfusion Pressure |
1.5; 1.4 | 0.9147 |
| SECONDARY Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) |
0.74; -0.94 | 0.0070 sig |
| SECONDARY Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) |
0.54; -0.43 | <0.0001 sig |
| SECONDARY Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) |
0.30; -0.16 | 0.0476 sig |
| SECONDARY Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) |
0.31; -0.14 | 0.0352 sig |
| SECONDARY Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) |
0.35; -0.17 | 0.0208 sig |
| SECONDARY Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) |
0.27; -0.11 | <0.0001 sig |
| SECONDARY Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) |
0.17; -0.07 | 0.0024 sig |
| SECONDARY Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) |
0.15; -0.06 | 0.0081 sig |
| SECONDARY Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) |
-0.007; -0.005 | 0.8191 |
| SECONDARY Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) |
-0.018; 0.000 | 0.0482 sig |
| SECONDARY Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio) |
-0.013; 0.005 | 0.0230 sig |
| SECONDARY Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio) |
-0.009; 0.004 | 0.1202 |
| SECONDARY Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM |
1.71; -0.84 | 0.0063 sig |
| SECONDARY Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM |
-0.24; -1.03 | 0.3347 |
| SECONDARY Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM |
0.58; -0.44 | 0.0094 sig |
| SECONDARY Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM |
0.51; -0.41 | 0.0009 sig |
| SECONDARY Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM |
0.56; -0.46 | 0.0067 sig |
| SECONDARY Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM |
0.03; 0.13 | 0.6938 |
| SECONDARY Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM |
0.24; -0.32 | 0.0805 |
| SECONDARY Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM |
0.38; 0.03 | 0.2451 |
| SECONDARY Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM |
0.60; -0.18 | 0.0323 sig |
| SECONDARY Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM |
0.09; -0.16 | 0.3440 |
| SECONDARY Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM |
0.29; -0.08 | 0.0119 sig |
| SECONDARY Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM |
0.26; -0.14 | <0.0001 sig |
| SECONDARY Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM |
0.16; -0.16 | 0.0137 sig |
| SECONDARY Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM |
0.18; 0.01 | 0.0866 |
| SECONDARY Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM |
0.10; -0.13 | 0.0656 |
| SECONDARY Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM |
0.20; 0.01 | 0.0626 |
| SECONDARY Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM |
-0.008; -0.005 | 0.8100 |
| SECONDARY Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM |
-0.005; -0.004 | 0.9556 |
| SECONDARY Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM |
-0.019; -0.004 | 0.3414 |
| SECONDARY Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM |
-0.017; 0.004 | 0.0330 sig |
| SECONDARY Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM |
-0.005; 0.005 | 0.3326 |
| SECONDARY Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM |
-0.022; 0.005 | 0.0348 sig |
| SECONDARY Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM |
-0.006; 0.010 | 0.2089 |
| SECONDARY Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM |
-0.012; -0.001 | 0.3738 |
| SECONDARY Change in Ocular Perfusion Pressure - DM |
0.2; -1.1 | 0.4470 |
| SECONDARY Change in Ocular Perfusion Pressure - No DM |
2.8; 3.8 | 0.6382 |
| SECONDARY Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM |
-0.031; 0.012 | 0.0026 sig |
| SECONDARY Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM |
-0.021; 0.010 | 0.1045 |
| SECONDARY Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM |
-0.005; 0.000 | 0.6941 |
| SECONDARY Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM |
-0.028; 0.018 | 0.0138 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01930487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.