CompletedNot Applicable

Foldable Capsular Vitreous Body Implantation Study

Belgium2 participantsStarted 2017-05-02

Plain-language summary

This study is intended to evaluate the clinical usefulness of the FCVB in its on-label use, but in a different racial type than studies till now (Asians only). The device will be inserted in Caucasian patients with permanent loss of functional vision (visual acuity hand movements or less), where a permanent use of repeat silicone oil is required to maintain the eye pressure.

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: * Patients aged over 18 * Axial length between 16 and 28 mm (according the guidelines from the manufacturer) * Loss of functional vision in study eye * Visual acuity of 0.4 or better in fellow eye * Requirement of (repeated) long-term silicone oil tamponade to maintain eye pressure and keep the retina attached Exclusion Criteria: * Visual acuity beyond 0.4 in non-study eye * Severe general disease that is evaluated to impact live expectancy beyond the duration of the study follow-up (3 years) * Retinal detachment under silicone oil fill * Patients with a silica gel allergy or scar diathesis * Patients with serious heart, lung, liver, or kidney dysfunction * Patients with proliferative diabetic retinopathy, endophthalmia, uveitis and other uncontrollable eye diseases, or a contralateral eye that had intraocular retinal surgery * Patients with history of drug abuse or alcoholism * Patients are had participating in other drug or medical device clinical trials before screening for this trial * Pregnancy, preparation for pregnancy during clinical trial, or breast-feeding * Belief by any of the research doctors that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

Intra-ocular pressure

Timeframe: 3 years

Trial details

NCT IDNCT03390244

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-02

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