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 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07480603
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 to 90 years.
Diagnosis of primary open-angle glaucoma meeting the following criteria:
* Intraocular pressure (IOP) not controlled by at least one (1) or more classes of topical IOP-lowering medications, and
* Eye without visual acuity.
Patients must be able to understand the study requirements and provide written informed consent.
Patients must be willing to follow study instructions, agree to comply with all study procedures, and be able to attend all scheduled follow-up visits for at least 6 months after surgery.
Exclusion Criteria:
* Previous filtering surgery, secondary glaucoma, severe systemic disease, pregnancy, breastfeeding, or inability to understand or provide informed consent.
Pregnant or breastfeeding women, or women of childbearing potential who are not willing to use a medically acceptable method of contraception from the screening visit until the 12-month follow-up visit.
Known or suspected allergy or hypersensitivity to any component of the device (e.g., silicone).
Current participation, or participation within the last 30 days (from the screening visit), in another investigational drug or interventional device clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT07480603
Study Brief:
Protocol Section:
NCT07480603