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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07326332
Eligibility Criteria:
Inclusion Criteria:
* Scheduled for elective angioplasty (coronary PCI or peripheral angioplasty) under local anesthesia with planned procedural sedation.
* Able to give informed consent and complete ocular symptom assessments.
* Baseline Schirmer I ≥1 mm (to exclude complete anatomic lacrimal failure; you may alter this cutoff).
Exclusion Criteria:
* Pre-existing moderate/severe dry eye disease or Sjögren's syndrome (history or OSDI \>33).
* Ocular surgery within prior 3 months or active ocular infection.
* Contact lens use within 24 hours before baseline.
* Chronic systemic medications known to substantially alter lacrimation (recent anticholinergics, high-dose tricyclics) unless stable and documented.
* Known allergy to dexmedetomidine, midazolam, fentanyl, or propofol.
* Significant bradycardia (HR \<50) or high-degree AV block without pacemaker.
* Pregnancy or breastfeeding.
* Any condition making study participation or follow-up impossible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07326332
Study Brief:
Protocol Section:
NCT07326332