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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT00145535
Eligibility Criteria:
Inclusion Criteria:Clinical Diagnosis of Open Angle Glaucoma
* Patient is aged 18 years or older, with 2 sighted eyes.
* Eye to be treated have average IOP greater or equal to 22 mmHg, measured at 2 pretreatment visits.
* Eye to be treated either exhibits:
* poorly controlled open angle glaucoma and on maximal tolerated medical therapy
* OR poorly controlled open angle glaucoma and failed previous laser trabeculoplasty (180° available to treat if previous ALT; can treat over previous SLT)
Exclusion Criteria:
Patients are not eligible for enrollment if any of the following exclusion criteria are met:
* Eye to be treated has any of the following:
1. evidence of glaucoma other than open-angle glaucoma;
2. severe paracentral or generalized field defect;
3. any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork.
4. prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy.
* Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.
* Patient is pregnant.
* Patient might require other ocular surgery within the 6-month follow-up period.
* Patient has a medical history that suggested the potential for complications from TiSaLT.
* Having concurrent treatment with systemic steroids.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00145535
Study Brief:
Protocol Section:
NCT00145535