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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT05326958
Eligibility Criteria:
Inclusion Criteria:
* All
* Able and willing to undergo the test procedures, give consent, and to follow instructions.
* Signed informed consent.
* ≥18 years.
* Part 1, Site 1
* Normal eyes of patients without Diabetes Mellitus
* Fasting blood glucose \< 100 mg/dl
* HbA1c ≤ 6.5%
* Part 2, Site 2
* Diabetes Mellitus Type 2 without coexisting DPN (NSS score ≤2 and / or NDS score ≤2)
* Diabetes Mellitus Type 2 with coexisting early to moderate DPN. (NSS score 3-4 and / or NDS score 3-5)
* 6.5% \< HbA1c ≤ 9.5%
Exclusion Criteria:
* Vulnerable subjects (Such as: individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel (if linked to CI site), employees of the sponsor, members of the armed forces (if linked to CI site or sponsor), and persons kept in detention.)
* Subjects unable to read or write
* Contact lens wearers (soft and rigid)
* Patients with symptomatic dry eye
* Patients with conjunctivitis at the time of inclusion
* Patients with history of corneal surgery
* Patients with diabetic retinopathy
* Patients with history of neuronal diseases that according to the expertise of the investigator might have an influence on corneal nerve fiber plexus
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05326958
Study Brief:
Protocol Section:
NCT05326958