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:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-26 @ 3:58 PM
NCT ID:
NCT01915706
Eligibility Criteria:
Inclusion Criteria:
* Men or women aged 18 years and older at screening. There is no upper age limit.
* Inadequately controlled glaucoma refractory to maximum therapy
* Suitable candidate for Baerveldt-350 implant in the superotemporal quadrant in the study eye, which the physician deems as medically necessary.
* Capable and willing to provide consent
Exclusion Criteria:
* Unable or unwilling to provide consent
* Any previous ocular surgery other than cataract extraction or trabeculectomy
* Any previous ocular surgeries in the study eye preventing placement of the Baerveldt-350 implant in the superotemporal quadrant
* Any abnormality other than glaucoma in the study eye that could affect tonometry.
* Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.
* Monocularity (where best corrected visual acuity in the non-operative eye is worse than 20/200)
* Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Known pregnant or breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01915706
Study Brief:
Protocol Section:
NCT01915706