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 @ 2:41 PM
Ignite Modification Date:
2025-12-24 @ 2:41 PM
NCT ID:
NCT07014059
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years
* Dry eye and/or chronic epithelial defects of the ocular surface with indication for autologous serum according to the evaluation of ophthalmologists specialized in Cornea and Ocular Surface;
* Peripheral venous access or PICC that allows the collection of whole blood.
Exclusion Criteria:
* Active ocular infection;
* Hemoglobin \< 11 g/dL;
* Angina, MI, or stroke in the last 30 days;
* Significant pulmonary or cardiac disease that contraindicates autologous serum collection in the investigator's opinion;
* Active ocular or systemic infection at the time of collection;
* Inability to attend follow-up visits at 6 and 12 weeks;
* Active hematological malignancy (except measurable residual disease) or solid malignancy (except non-melanoma skin cancer);
* Positive for HIV, HCV, HBV, HTLV, Chagas disease, or syphilis;
* Life expectancy \< 6 months;
* Not pregnant (as reported by the participant).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07014059
Study Brief:
Protocol Section:
NCT07014059