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 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT01212861
Eligibility Criteria:
Inclusion Criteria:
* Available for up to 3 years follow-up.
* Diagnosed with primary open-angle, pseudoexfoliative, or pigmentary glaucoma or more than one glaucoma diagnosis of these types.
* Subject scheduled to undergo glaucoma surgery with the Suprachoroidal Dissection Instrument involving creation of fistula between Schlemm's canal and the suprachoroidal space without combined cataract surgery.
* Subject has failed at least one incisional glaucoma surgery (trabeculectomy, tube shunt, deep sclerectomy, viscocanalostomy, canaloplasty) or angle surgery (Trabectome) OR Is not a candidate for conventional glaucoma surgery due to reasons such as the presence of scleral buckle or compromised conjunctiva.
* Subject has IOP ≥ 16 mm Hg on maximally tolerated medications within the six week (-42 days) period prior to surgery.
* Visual field defect defined as mean deviation (MD) score worse than or equal to -10 dB on the Swedish Interactive Threshold Algorithm \[SITA\] Standard 24-2 Humphrey Analysis during the 6 month period prior to surgery. OR Subject has vertical cup-to-disk ratio ≥ 0.75 during the 6 month period prior to surgery.
Exclusion Criteria:
* Significant lens opacities or patient is candidate for cataract surgery during the duration of the study.
* The patient had developmental glaucoma or a secondary glaucoma including steroid-induced, uveitic, or neovascular glaucoma (with the exception of pigmentary and pseudoexfoliative glaucoma).
* The patient has narrow angle component possibly associated with glaucoma in the operative eye.
* The subject has angle recession in the operative eye.
* Significant ocular disease other than glaucoma affecting the assessment of visual function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01212861
Study Brief:
Protocol Section:
NCT01212861