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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT05689333
Eligibility Criteria:
Inclusion Criteria:
* Male or female participant with age ≥ 18 years at the time of screening.
* Subject must have a clinical indication for anterior vitrectomy.
* Subjects must be able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
* Subjects must be willing and able to comply with all treatment and follow-up study procedures.
Exclusion Criteria:
* Subjects who have experienced any significant trauma in the operative eye within the past month.
* Subjects with any active ocular infection or history of any herpetic infection that has cleared less than one month prior to the pre-operative visit.
* Subjects with prior history of uncontrolled glaucoma or uveitis refractory to treatment or ocular hypertension (IOP\>30mm Hg) in study eye.
* Subjects with any medical condition (e.g., uncontrolled diabetes) that, based on the Investigator's medical judgment, poses a concern for the subjects' safety.
* Female subjects of child bearing potential with positive urine pregnancy test
* Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into or during this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05689333
Study Brief:
Protocol Section:
NCT05689333