Recruiting

Carotenoid Vitamins

Sponsor:

ZeaVision, LLC

Code:

NCT04117022

Conditions

Diabetes

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

DVS supplementation

Study Details

Brief summary:

To evaluate the differences in retinal function as measured by ERG in diabetics with and without retinopathy 2) the ability of the Chromatic Electroretinogram (chERG) to detect changes in global retinal function following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR). 3) the ability of the Full Field flicker (ffERG) to detect changes in global retinal function following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR).

4) Changes in retinal function as observed by OCT-Angiography, following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR).

Conditions

Diabetes

Diabetic Retinopathy

Study ID

NCT04117022

Start date

Sep 1, 2019

Status verified date

Apr, 2021

Completion date

Dec 1, 2022

Anticipated

Primary completion date

Dec 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 21-80 years

1. History of Diabetes for at least > 5years
2. No retinopathy, Mild or Moderate Non-Proliferative diabetic retinopathy

  • Diabetes without retinopathy (Appendix A)
  • Mild to moderate NPDR as defined by the American Academy of Ophthalmology7 (Appendix A)

Exclusion Criteria:

  • • History of any systemic or ophthalmic condition (other than diabetic retinopathy) capable of affecting vision

  • Presence of Diabetic Macular Edema
  • History of intraocular surgery, including macular or panretinal photocoagulation laser (except uncomplicated cataract or keratorefractive surgery more than 6 months prior to enrollment)
  • History of treatment affecting vision, influencing reaction time and/or drugs indicating severe general diseases (eg. Hydroxychloroquine, tamoxifen, dexamethasone, triamcinolone, fluocinolone, etc.)
  • Spherical refraction outside ±5.0 D or cylinder correction outside ±3.0 D
  • Inability to obtain reliable Chromatic ERG test
  • Pregnant and nursing women
  • Allergy to the supplement or any of its ingredients
  • Any subject that all ERG study tests or the OCT angiography cannot be obtained reliably.

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: supplemented arm

Each subject will receive DVS formula, 2 softgels per day for 6 months.

Interventions

DVS supplementation

Oral supplement. Each subject will be given the carotenoid supplement of DVS formula. The DVS formula consists of vitamins C, D3 and E (d-α tocopherol), zinc oxide, eicosapentaenoic acid, docosahexaenoic acid, α-lipoic acid (racemic mixture), coenzyme Q10, mixed tocotrienols/tocopherols, zeaxanthin, lutein, benfotiamine, N-acetyl cysteine, grape seed extract, resveratrol, turmeric root extract, green tea leaf, and Pycnogenol (patented French Maritime Pine Bark extract, sp Pinus pinaster, Horphag Research, Geneva, Switzerland). Supplements bottles will be labelled with a unique identification number for each subject and supplied by ZeaVision, LLC, Chesterfield, Missouri, USA. To assure that the participants do not have any issues with the vitamin supplement and to ensure adequate adherence to schedule of vitamin intake the participants will get regular phone calls from the study investigators (once every two weeks).

Primary outcome measure

  • Chromatic ERG (ChERG) Outcome Measurements: B wave and PhNR latency (milliseconds) Full field ERG outcome measurements and Chromatic ERG Outcome Measurements [ Time Frame: Change from Baseline to 6 months ]
  • Full-field flicker ERG (ffERG) Measurements: magnitude (microvolts) and the phase (milliseconds) and the area ratio for magnitude and the area ratio for Phase [ Time Frame: Change from Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Pinakin Davey, OD, PhD

909-469-8473 |pdavey@westernu.edu

Nathan Lighthizer, OD

918-444-4007lighthiz@nsuok.edu

Locations

Western Universit5y of Health Sciences, College of Optometry

Recruiting

Pomona, California, United States, 91766

Contacts

Pinakin G. Davey, OD, PhD

901-831-1562contact@pinakin-gunvant.com

Ida Chung, OD, MSHE

909-469-8687ichung@westernu.edu

Oklahoma College of Optometry, Northeastern State University

Recruiting

Tahlequah, Oklahoma, United States, 74464

Contacts

Nathan R. Lighthizer, OD

918-444-4007lighthiz@nsuok.edu

Richard E. Castillo, OD

(918) 444-4038castillo@nsuok.edu

Principal Investigator:

Pinakin Davey, OD, PhD

More Information

Sponsor

ZeaVision, LLC

Last update posted

Apr 23, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ZeaVision, LLC on 2021-04-23.