This study is evaluating the impact of an education program plus nutritional supplements on the frequency of eye disease in patients with diabetes mellitus. The main outcome to be measured will be the changes in electroretinogram results, a lab test that measures vision quality. This study is recruiting in North Carolina.
The details
Some patients with diabetes may develop problems with their vision due to diabetic retinopathy (DR). This is a disease that damages the blood vessels in the retina (the back of the eye). High blood glucose levels can damage these vessels, leading to vision loss. Educating patients on diabetes management is essential to help lower the risk of DR. Certain nutritional supplements, such as omega-3, may also help improve eye health.
This study will investigate whether patient education and nutritional supplements can help reduce the risk of DR in patients with diabetes or pre-diabetes. The main outcome measured will be the change in electroretinogram results at the end of the program.
Who are they looking for?
This study is looking for 150 to 200 adults with prediabetes, Type 1 diabetes, or Type 2 diabetes. Participants should not have DR. However, patients with mild to moderate DR may be able to participate if there is no damage to the macula (the center of the retina). Participants should have at least 20/30 corrected vision in each eye.
Patients with less than 20/30 corrected vision in either eye cannot participate. Patients with other serious eye diseases such as glaucoma cannot participate. Patients with a history of eye surgery cannot participate. Women who are pregnant or breastfeeding cannot participate.
How will it work
All patients will be enrolled in the education program, which will last for 12 months. Patients will be divided into three groups with different nutritional supplements. The first group will receive a placebo nutritional supplement. The second and third groups will receive an oral supplement for eye health (EyePromise DVS). The third group will also receive an omega-3 supplement.
The main outcome measured will be the change in electroretinogram results at the end of the program. Patients will be followed up at 1, 3, 6, 9 and 12 months. Follow-up will involve eye exams and assessments about the education program.
