Recruiting

Diabetes Education & Nutritional Supplementation

Sponsor:

ZeaVision, LLC

Code:

NCT04120077

Conditions

Diabetes Mellitus

Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

EyePromise DVS, EyePromise DVS plus EyePromise EZTears

Study Details

Brief summary:

The purpose of this study is to evaluate the combined effects of diabetes self-management education (DSME) and nutritional supplementation on visual function and retinopathy incidence \& progression in patients with type 1 diabetes, type 2 diabetes and pre-diabetes.

Conditions

Diabetes Mellitus

Diabetic Retinopathy

Study ID

NCT04120077

Start date

Jan 1, 2020

Status verified date

Apr, 2021

Completion date

Jan 1, 2022

Anticipated

Primary completion date

Jan 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • diagnosed prediabetes, type 1 or type 2 diabetes
  • no diabetic retinopathy (DR), mild DR or moderate DR without center-involved macular edema
  • age > 18 years
  • ability to give informed consent
  • best corrected visual acuity > 20/30 in each eye.

Exclusion Criteria:

  • no formal diagnosis of prediabetes or diabetes
  • age < 18 years
  • inability to give informed consent
  • best corrected visual acuity < 20/30 in either eye
  • center-involved DME by spectral domain optical coherence tomography \* evidence of severe non-proliferative or proliferative diabetic retinopathy
  • evidence of other serious ocular disease (age-related macular degeneration, glaucoma, significant media opacity)
  • history of intraocular surgery, including macular or panretinal photocoagulation or prior intra-ocular injection of anti-Vascular endothelial growth factor (anti-VEGF) drugs (except uncomplicated cataract or keratorefractive surgery more than 6 months prior to enrollment)
  • pregnant and nursing women
  • known sensitivity to any of the supplement ingredients.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: DSME + placebo supplement (group 1)

Subjects will receive 10-session DSME delivered in a group setting by their optometrist. Subjects be instructed to consume two capsules (canola oil soft-gels) per day in the morning and two capsules per day in the evening along with food and six to eight ounces of water, and continue their normal dietary, exercise and medication regimens. Baseline and 3,6,9, 12-month assessments of color perception, 10-degree visual field, flicker electroretinogram (ffERG), glycosylated hemoglobin, diabetic retinopathy severity and optical coherence tomography/optical coherence tomography angiography (OCT/OCTA) parameters will be assessed. Serum vitamin D, glycohemoglobin and high-sensitivity C-reactive protein (hsCRP) and macular pigment density will be assessed at baseline, 6 and 12 months.

experimental: DSME + DVS supplement (group 2)

Subjects will receive 10-session DSME delivered in a group setting by their optometrist. Subjects will be instructed to consume two capsules per day (EyePromise DVS nutritional supplement) in the morning and two capsules per day (canola oil placebo) in the evening along with food and six to eight ounces of water, and continue their normal dietary, exercise and medication regimens. Baseline and 3,6,9, 12-month assessments of color perception, 10-degree visual field, flicker electroretinogram (ffERG), glycosylated hemoglobin, diabetic retinopathy severity and optical coherence tomography/optical coherence tomography angiography (OCT/OCTA) parameters will be assessed. Serum vitamin D, glycohemoglobin and high-sensitivity C-reactive protein (hsCRP) and macular pigment density will be assessed at baseline, 6 and 12 months.

experimental: DSME + DVS supplement + omega-3 supplement (group 3)

Subjects will receive 10-session DSME delivered in a group setting by their optometrist. Subjects will be instructed to consume two capsules per day (EyePromise DVS nutritional supplement) in the morning and two capsules per day (EyePromise EZTears) in the evening along with food and six to eight ounces of water, and continue their normal dietary, exercise and medication regimens. Baseline and 3,6,9, 12-month assessments of color perception, 10-degree visual field, flicker electroretinogram (ffERG), glycosylated hemoglobin, diabetic retinopathy severity and optical coherence tomography/optical coherence tomography angiography (OCT/OCTA) parameters will be assessed. Serum vitamin D, glycohemoglobin and high-sensitivity C-reactive protein (hsCRP) and macular pigment density will be assessed at baseline, 6 and 12 months.

Interventions

EyePromise DVS, EyePromise DVS plus EyePromise EZTears

Placebo Comparator: American Association of Diabetes Educators (AADE) certified Diabetes Self-Management Education (DSME) with placebo nutritional supplements

Primary outcome measure

  • full-field flicker electroretinogram (ffERG) implicit time (milliseconds) [ Time Frame: Change from baseline to 12 months ]
  • full-field flicker electroretinogram (ffERG) amplitude (microvolts) [ Time Frame: Change from baseline to 12 months ]
  • glycosylated hemoglobin (HbA1c) percentage [ Time Frame: Change from baseline to 12 months ]

Central Contacts and Locations

Central contacts

Paula R. Newsome, OD

(704) 375-3935paulanews@aol.com

Ansel T. Johnson, OD

(708) 385-0013nfo@visionsalon.com

Locations

Advantage Vision Center

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Paula R. Newsome, OD

704-375-3935paulanews@aol.com

Tempest Bryant

704-375-3935appts@advantagevisioncenter.com

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.