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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT06517667
Eligibility Criteria:
Inclusion Criteria:
1. Self-reported history DED.
2. Ocular surface disease index (OSDI) \> 13 points.
3. Non-invasive tear film break-up time (NIBUT) \< 10 s.
4. Schirmer test (ST) without anesthesia ≥ 5 mm.
5. MGD grade \> 1. For MGD, the Sirius device (CSO, Florence, Italy) was used, which determines MGD grade based on loss area of meibomian glands (LAMG). MGD grade was scored from 0 to 4 (MGD grade 1 = LAMG \< 25%; MGD grade 2 = LAMG ≥ 25% and \< 50%; MGD grade 3 = LAMG ≥ 50% and \< 75%; MGD grade 4 = LAMG ≥ 75%).
Exclusion Criteria:
1. Abnormal lid anatomy, including active blepharitis, and active lid margin.
2. All corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies.
3. Active ocular allergies.
4. Vectored thermal pulsation (VTP) intense pulse light (IPL), quantum molecular resonance (QMR), or other procedure to treat DED within the previous 6 months.
5. Intraocular surgery or laser ocular surgery within the previous 6 months.
6. Use of topical antibiotics and anti-inflammatory treatments, including steroids and non-steroidal anti-inflammatory drugs.
7. Systemic autoimmune diseases.
8. Contact lens wearers.
9. Pregnant or lactating women.
10. Patients who did not understand or comprehend the informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06517667
Study Brief:
Protocol Section:
NCT06517667