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 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT03548805
Eligibility Criteria:
Inclusion Criteria:
1. Age between 10 to 40 years (inclusive)
2. Uncontrolled IOP (defined as IOP \> 21 mm Hg) despite maximum tolerable antiglaucoma therapy
3. Open anterior chamber angle on gonioscopic examination
4. Glaucomatous optic disc damage on clinical examination (focal or diffuse neuroretinal rim thinning, localized notching or nerve fiber layer defects) with corresponding visual field (VF) defects
5. Patientor his/her guardian is willing and able to comply with study procedures and sign informed consent
Exclusion Criteria:
1\. Patients with steroid-induced glaucoma and other types of secondary open angle glaucoma 2. Juvenile-onset Open Angle Glaucoma eyes that underwent trabeculectomy with MMC or had a previous filtering surgery 3. Patients with any other ocular disease that may expose them to an undue risk of a significant adverse event during the course of the study, including but not limited to ocular cancer, trauma, corneal surface damage or other conditions as determined by the clinical judgment of the investigator 4. Patient with single functional eye 5. Participation in any study 30 days prior to trabeculectomy 6. Pregnant or breast-feeding women
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
40 Years
Study:
NCT03548805
Study Brief:
Protocol Section:
NCT03548805