Status:
UNKNOWN
Diabetic Retinopathy Functional Evaluation Study: Monitoring Carotenoid Vitamins Treatment Using ERG
Lead Sponsor:
ZeaVision, LLC
Collaborating Sponsors:
Northeastern State University
Western University of Health Sciences
Conditions:
Diabetes
Diabetic Retinopathy
Eligibility:
All Genders
21-80 years
Phase:
NA
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 retin...
Detailed Description
This prospective, study has cross-sectional analysis of ERG functions in a group of diabetics with and without retinopathy. Both Chromatic ERG and Full field ERG (NOVA, Diopsys, Inc. Pine Brook, NJ) w...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- • 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04117022
Start Date
September 1 2019
End Date
December 1 2022
Last Update
April 23 2021
Active Locations (2)
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1
Western Universit5y of Health Sciences, College of Optometry
Pomona, California, United States, 91766
2
Oklahoma College of Optometry, Northeastern State University
Tahlequah, Oklahoma, United States, 74464