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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT04808804
Eligibility Criteria:
Inclusion Criteria:
* All patients with confirmed type 2 DM diagnosis of at least 6 months
* Best-corrected visual acuity (BCVA) of 6/12 or higher (using a Snellen chart) in each eye
* Intraocular pressure (by applanation) less than 21 mmHg.
* Healthy controls had no record nor evidence of ocular or neurologic disease of any kind; their BCVA is \> 6/9 based on the Snellen scale.
Exclusion Criteria:
* presence or past history of moderate or severe non proliferative diabetic retinopathy or proliferative diabetic retinopathy , confirmed by indirect funduscopy or retinography images.
* presence of significant refractive errors (≥5 diopters of spherical equivalent refraction or 3 diopters of astigmatism)
* intraocular pressure ≥21 mmHg
* media opacifications
* concomitant ocular diseases, including history of glaucoma or retinal pathology
* systemic conditions that could affect the visual system, including neurodegenerative disorders such as Parkinson's disease, multiple sclerosis, or dementia.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04808804
Study Brief:
Protocol Section:
NCT04808804