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:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT04905459
Eligibility Criteria:
Inclusion Criteria:
1. Documented diagnosis of Type I or Type II diabetes mellitus:
meet the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
2. Age 22 or older
3. Understand the study and volunteer to sign the informed consent
Exclusion Criteria:
1. Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses).
2. Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion.
3. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
4. Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy.
5. Currently participating in an interventional study.
6. Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation, etc.).
7. Participant is contraindicated for imaging by fundus imaging system used in the study; e.g.
1. Participant is hypersensitive to light (side effect of medication or due to unknown etiology)
2. Participant has undergone photodynamic therapy (PDT)
3. Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops).
8. Known pregnancy or possibility of pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT04905459
Study Brief:
Protocol Section:
NCT04905459