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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT01883856
Eligibility Criteria:
Inclusion Criteria:
* Male or female of any race ≥ 18 years and ≤ 80 years of age.
* Diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy.
* Elevated intraocular pressure \> 21 mmHg in the study eye. Two consecutive measurements using Goldmann Applanation Tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure.
* Subject is a candidate for surgery in the study eye with a glaucoma drainage device.
* Subject is willing and able to sign the informed consent.
Exclusion Criteria:
* Diagnosis of silicone oil endotamponade induced glaucoma in the study eye.
* History of prior drainage implant surgery in the study eye.
* History of cyclophotocoagulation of the study eye.
* Pregnancy.
* Prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01883856
Study Brief:
Protocol Section:
NCT01883856