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 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT04612868
Eligibility Criteria:
Inclusion Criteria:
* Age ≥22
* Male or female
* Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO).
* Understand the study and volunteer to sign the informed consent
Exclusion Criteria:
* Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
* Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
* History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
* Currently participating in another investigational eye study and actively receiving investigational product for Diabetic Retinopathy (DR) or Diabetic Macular Edema (DME).
* 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).
* Participant is contraindicated for imaging by fundus imaging systems used in the study:
1. Participant is hypersensitive to light
2. Participant recently underwent photodynamic therapy (PDT)
3. Participant is taking medication that causes photosensitivity
4. Participant has a history of angle-closure glaucoma or narrow anterior chamber angles
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT04612868
Study Brief:
Protocol Section:
NCT04612868