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OpenTrials
Completed

NCT Number: NCT01930487

The Effects of an Antioxidant Formulation on Ocular 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.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glick Eye Institute, Ocular Vascular Research Center, Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dietary supplement with antioxidants

Dietary Supplement

Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids

Other names: Optic Nerve Formula

Placebo

Dietary Supplement

Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

Sponsors and collaborators

Lead sponsor

ScienceBased Health

Industry

Registry information

Official study title

The Effects of an Antioxidant Formulation on Intraocular Pressure, Ocular Perfusion Pressure, Retrobulbar, Retinal Capillary and Choroidal Blood Flow

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 29, 2013
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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