Diabetic Retinopathy Functional Evaluation Study: Monitoring Carotenoid Vitamins Treatment Using ERG

Status unconfirmed · Not applicable

Conditions studied: Diabetes, Diabetic Retinopathy

In brief

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).

Key facts

Study ID

NCT04117022

Run by

ZeaVision, LLC

People needed

45

Starts

2019-09-01

Expected to finish

2022-12-01

Last updated by the study team

2021-04-23

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21-80 years
• History of Diabetes for at least > 5years
• 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)

You may not qualify if…

• • 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.

Where it is running

• Western Universit5y of Health Sciences, College of Optometry — Pomona, California, United States (enrolling)
• Oklahoma College of Optometry, Northeastern State University — Tahlequah, Oklahoma, United States (enrolling)

Full record on ClinicalTrials.gov

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