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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT06713720
Eligibility Criteria:
Inclusion Criteria:
* Age between 40 and 80 years.
* Diagnosed with Type 2 diabetes mellitus.
* Diagnosed with mild to moderate non-proliferative diabetic retinopathy (NPDR) with a DR Severity Score (DRSS) grade of 20-47D.
* Capable of performing daily activities independently.
* Willing and able to provide informed consent.
Exclusion Criteria:
* Presence of diabetic macular edema (macular thickness \> 250 μm).
* Significant eye diseases affecting evaluation, such as high myopia, severe cataract, corneal leucoma, glaucoma, retinal detachment, retinal vein occlusion, congenital eye diseases, ocular tumors, or severe infection.
* History of ocular laser or intraocular surgery.
* Poor imaging quality due to refractive media opacity.
* Contraindication to fluorescein fundus angiography.
* Unstable blood glucose (HbA1c ≥ 8.0%) despite oral antidiabetic drugs.
* Severe diabetes complications within the past 6 months.
* Severe, sustained hypertension (systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg).
* Body mass index (BMI) ≥ 28 kg/m².
* Hepatic or renal insufficiency: Alanine aminotransferase or aspartate aminotransferase \> 2 times the upper limit of normal. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m². Urine albumin/creatinine ratio ≥ 30 mg/g.
* Myocardial infarction within the past 6 months.
* Neurological diseases such as Alzheimer's, Parkinson's, cerebrovascular disease, intracranial tumor, cerebrovascular malformation, or aneurysm.
* Contraindications to RIC, including one-sided subclavian artery stenosis, upper limb injuries or vascular diseases, or limb deformities.
* Severe systemic diseases, such as malignant tumors with a life expectancy of less than 24 months.
* Known pregnancy or breastfeeding.
* Participation in other experimental clinical studies.
* Any other conditions deemed unsuitable by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT06713720
Study Brief:
Protocol Section:
NCT06713720