A Study for Assessing the Safety of Hanita Glaucoma Shunt in Glaucoma Patients

Summary

Participation Requirements

Description

Study Design: This study is a prospective, single-arm single-center, open-label study. Study population: Men and women diagnosed with open-angle glaucoma who require glaucoma surgery procedures that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the st...

Study Design: This study is a prospective, single-arm single-center, open-label study. Study population: Men and women diagnosed with open-angle glaucoma who require glaucoma surgery procedures that meet the inclusion/exclusion criteria and provide written informed consent will be enrolled in the study. Enrollment: A total of 30 subjects will be enrolled: 15 patients will be implanted according to procedure 1 (see section 8.7), at completion additional 15 patients will be implanted according to procedure 2 (see section 8.7) Investigational sites: One (1) center will participate in this study. Duration of Subject participation: Completion of active enrolment is anticipated to last approximately 6 months. The primary endpoint will be achieved when the final study subject has completed 6 months follow-up. Study Group: A single study group. This is a single-arm design; there is no control device in this study. Visits & Procedures Pre-operative visit: 0-3 months prior to the implantation procedure. The visit will include the subject's qualification assessment for inclusion/exclusion criteria as described above. Informed consent must be signed. Complete anamnesis will be taken including the subject's medical complaints, medical history, and medication use. Ophthalmic examinations as well as ultrasound biomicroscopy. Surgical procedure: Procedure will be performed under anesthesia (at physician discretion) and a Hanita shunt will be implanted. Follow-up: All subjects will have regular follow-up visits at 1 and 7 days and on 1, 3, and 6 months post-implantation. 1-year post-operative evaluation is optional at the sponsor's discretion. All postoperative visits will include a complete ophthalmic examination,

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