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 range
18 Years
Sex
ALL
See this in plain English?
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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying a device called CID v2.2 in glaucoma surgery — can you explain what this device is, how it works differently from other surgical options for my type of glaucoma, and whether my diagnosis of open-angle or narrow-angle glaucoma would even be relevant to what this study was testing?
2Since the trial is listed as 'active not recruiting,' it's no longer enrolling new patients — does that mean results might be available soon, and would it be worth waiting to see those findings before deciding on my own surgical approach?
3The main thing this trial was measuring is how much it reduces eye pressure after surgery — based on what you know about this device so far, how does that potential pressure reduction compare to the standard surgical procedures you'd normally recommend for me?
4Because this trial is listed as Phase NA rather than a standard Phase 1, 2, or 3, what does that tell us about how much safety and effectiveness data exists for this device, and how should that uncertainty factor into my decision-making?
5If this trial's results turn out to be promising, how long do you think it would realistically take before a device like CID v2.2 might become available outside of a clinical trial setting, and what would you recommend I do in the meantime to manage my glaucoma?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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