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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT05806957
Eligibility Criteria:
Inclusion Criteria:
1. Aged at least 22 years old.
2. A documented history of Diabetes Mellitus, defined as any of the following:
* Hemoglobin A1c (HbA1c) ≥ 6.5% based on repeated assessments
* Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) based on repeated assessments
* Oral Glucose Tolerance test with 2-hour plasma glucose ≥ 200 mg/dL (11.1mmol/L) using equivalent of 75g anhydrous glucose dose in water.
* Symptoms of hyperglycemia or hyperglycemic crisis with random plasma glucose ≥ 200mg/dL (11.1 mmol/L)
* Criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA).
3. Willing to undergo fundus photography by up to 4 different methods and/or cameras.
4. Has signed a written informed consent form prior to study participation.
Exclusion Criteria:
1. Diagnosed with uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.
2. Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
3. Has a positive history for laser treatment of the retina or injections into either eye, or any history of retinal surgery.
4. Is currently participating in another investigational eye study and actively receiving investigational product for DR or Diabetic Macular Edema (DME).
5. 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).
6. Is contraindicated for imaging by fundus imaging systems used in the study:
* hypersensitive to light
* recently (within 6 months) underwent photodynamic therapy (PDT)
* taking medication that causes photosensitivity
* positive history for angle-closure glaucoma or narrow anterior chamber angles
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT05806957
Study Brief:
Protocol Section:
NCT05806957