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:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2025-12-24 @ 2:05 PM
NCT ID:
NCT00382395
Eligibility Criteria:
Inclusion Criteria:
* Primary open-angle, pseudoexfoliative, or pigmentary glaucoma
* Age 21 or over
* refractory glaucoma, with IOP \>21 mmHg on medications and failed prior incisional glaucoma surgery
* detectable visual field defect (negative MD score)
* written consent
* available for up to 24 months follow-up
Exclusion Criteria:
* either eye with VA worse than count fingers
* recent angle closure glaucoma episode
* uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
* other significant ocular disease, except cataract
* active ocular infection
* expected ocular surgery in next 12 months
* no suitable quadrant for implant
* systemic corticosteroid therapy \> 5 mg/day prednisone
* intolerance to gonioscopy or other eye exams
* mental impairment interfering with consent or compliance
* pregnancy
* known sensitivity to anticipated medications used at surgery
* significant co-morbid disease
* concurrent enrollment in another drug or device study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00382395
Study Brief:
Protocol Section:
NCT00382395