Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery (NCT05625958) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery
Spain29 participantsStarted 2023-03-23
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open and narrow angle glaucoma who have failed at least one class of topical medical therapy
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 years or older
✓. Able to understand study requirements
✓. Able and willing:
✓. To provide written consent on the EC-approved Informed Consent Form,
✓. To comply with all study requirements, including required study follow-up visits' agenda
✓. Glaucoma (angle from 1 to 4 according to Schaffer grade), including pseudo exfoliative and pigmentary glaucoma, which meets the following:
✓. Vertical C/D ratio on fundoscopic exam ≤ 0.9, or OCT demonstrating a thinness of the nerve fibre layer at the p\<5% level as defined by the instrument's built-in age-adjusted normative database,
✓. Glaucoma visual field with -15 \< MD \< 0dB (Humphrey) or 0 \< MD \< 15 dB (Octopus)
Exclusion criteria
✕. Patient with a known allergy to any of the constituents of the products used in this study or known steroid responder
✕. Patient already included in another study
✕. A person protected by law (temporary or permanent guardianship) or not capable of discernment
✕. Patient who may not assist to all follow-up visits (because of frequent travelling, or living in remote area, or limited moving capacities, …)
. Pregnant or nursing woman at the date of inclusion (only for women of childbearing potential: positive urine pregnancy test at screening)
✕. With uncontrolled systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent the subject from completing all study visits (e.g. inability to reliably complete visual field testing over the course of the study, or take glaucoma medications (e.g. Parkinson's disease), or uncontrolled systemic disease (diabetes, hypertension) that could compromise participation in the study, …)
✕. Who have a new or modified prescription for a systemic treatment that could influence IOP within one month prior to inclusion, or who are aware of a future change in their systemic treatment, or if their medical condition indicates that their systemic treatment may change in the future
✕. Chemotherapy in the last 6 months before surgery