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 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT04468633
Eligibility Criteria:
Inclusion Criteria:
* Men or women with age at screening ≥ 18 years and ≤ 90 years
* Inadequately controlled glaucoma
* Valve-less aqueous shunt as the planned surgical procedure
* Patients with primary glaucomas or pseudoexfoliation, pigmentary and traumatic glaucoma with a previous failed trabeculectomy or other intraocular surgery included.
* Primary tubes included
* Investigators to recruit consecutively all eligible patients from their clinics.
* Superotemporal or inferonasal placement of the tube
* Capable and willing to provide consent
Exclusion Criteria:
* NLP
* Unable/unwilling to provide informed consent
* Unavailable for regular follow up
* Previous cyclodestructive procedure
* Prior scleral buckling procedure or other external impediment to supratemporal drainage device implantation
* Presence of silicone oil
* Vitreous in the anterior chamber sufficient to require a vitrectomy
* Uveitic glaucoma
* Neovascular glaucoma
* Nanophthalmos
* Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
* Procedure combined with other surgery
* Any abnormality other than glaucoma in the study eye that could affect tonometry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04468633
Study Brief:
Protocol Section:
NCT04468633