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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT02876393
Eligibility Criteria:
Inclusion Criteria:
Group 1 (Healthy controls without DM):
* Persons older than 18 years without DM
* Fundus free of any signs of retinal disease
* Best Corrected Visual Acuity of 20/40 (73 ETDRS letters) in both eyes
Group 2 (Persons with DM with no retinopathy):
* Persons with Type 1 or type 2 diabetes older than 18 years
* Normal fundus, Absence of features of DR or DMO in both eyes
* Best Corrected Visual Acuity 20/40 (73 ETDRS letters) in at least one eye
Group 3:
* Persons with Type 1 or type 2 diabetes 18 years and older
* Fundus signs of mild, moderate or severe DR and or DMO
* Best Corrected Visual Acuity 20/200 (33 ETDRS letters) or better
Exclusion Criteria:
* Recent ocular surgical procedures performed within the previous 3 months
* Presence of ocular confounding disorders such as neovascular age related macular degeneration, glaucoma or active uveitis
* Serious life threatening conditions that would preclude attendance in the longitudinal part of the study
* Neurological conditions that can impair vision
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02876393
Study Brief:
Protocol Section:
NCT02876393