RecruitingNot ApplicableNCT05625958

Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery

Multicentre, Non-randomised Clinical Study Evaluating the Safety and Efficacy of a Cilioscleral Interposition Device ("CID") v2.2 in Glaucoma Surgery


Sponsor

Ciliatech

Enrollment

29 participants

Start Date

Mar 23, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a small drainage device called CID v2.2, which is implanted in the eye to lower pressure in people with glaucoma. It is designed for patients whose eye pressure is not adequately controlled by 1 to 3 glaucoma eye drop medications and who need glaucoma surgery (without cataract surgery at the same time). **You may be eligible if...** - You are 18 or older with open-angle glaucoma (including pigmentary or pseudoexfoliative types) - Your eye pressure is not sufficiently controlled on 1 to 3 medications - Your eye pressure is between 18 and 30 mmHg (or 18–25 mmHg if on 3 medications) - Your visual field loss is mild to moderate (not worse than -15 dB) - Your corneal thickness is within a specific range (480–620 micrometers) - You are scheduled for glaucoma surgery alone (not combined with cataract surgery) **You may NOT be eligible if...** - You have a known allergy to the device materials or are a known steroid responder - You have had prior glaucoma surgery - You have certain types of glaucoma (such as angle-closure, neovascular, or uveitic glaucoma) - You have severe or rapidly progressing glaucoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECilioscleral Interposition Device

Surgical placement of SV22 cilioscleral interposition device in the supraciliary space


Locations(6)

Hospital Clínic of Barcelona

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Clínico San Carlos. Servicio de Oftalmología

Madrid, Spain

OMIQ Research

Sabadell, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Hospital Universitario Miguel Servet. Servicio de Oftalmología.

Zaragoza, Spain

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NCT05625958


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