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 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT07270133
Eligibility Criteria:
Key Inclusion Criteria:
* Age ≥ 18 years
* Diagnosed with Type 1 or Type 2 diabetes or non-diabetic control patients
* Best corrected visual acuity 20/32 or better (Snellen) (≥74 ETDRS letters)
* Meets criteria for one of the defined observational groups below
* Able and willing to provide informed consent
Key Exclusion Criteria:
* Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina
* Previous treatment of any kind for diabetic retinopathy or DME
* Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)
* History of rhegmatogenous retinal detachment or macular hole
* History of vitrectomy
* Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months
* Requiring treatment for DR/DME in the next 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07270133
Study Brief:
Protocol Section:
NCT07270133