Foldable Capsular Vitreous Body Implantation Study (NCT03390244) | Clinical Trial Compass
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 range18 Years
SexALL
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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