Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT07222293
Eligibility Criteria:
Inclusion Criteria:
1. Ability to sign and date the informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Age (≥)21 years of age or older
4. Diagnosed with diabetes mellitus as per criteria established by the World Health Organization (WHO) or the American Diabetes Association (ADA)
1. Hemoglobin A1c (HbA1c) ≥ 6.5%
2. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
3. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
Exclusion Criteria:
1. Persistent visual impairment in one or both eyes;
2. History of macular edema or retinal vascular (vein or artery) occlusion;
3. History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
4. Subject is contraindicated for fundus photography (for example, has light sensitivity);
5. Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
6. Subject is currently enrolled in an interventional study of an investigational device or drug for the same condition; or
7. Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs
8. Subject falls into one of the below categories:
* Adults unable to consent (individuals w/ impaired decision-making capacity)
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07222293
Study Brief:
Protocol Section:
NCT07222293