Foldable Capsular Vitreous Body Implantation Study

Not Applicable

Completed

• Conditions: Vitreoretinal Surgery
• Interventions: Device: Foldable Capsular Vitreous Body Implant

• Registration Number: NCT03390244
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-08
• Study Start: 2017-05-02
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2018-01-04
• Primary Completion: 2020-05-02
• Study Completion: 2020-05-05
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FCVB Implant	Foldable Capsular Vitreous Body Implant	All subjects in this study are in the experimental treatment arm and will receive the FCVB implant

Primary Outcome Measures

Name	Time	Method
Intra-ocular pressure	3 years	Evaluation of the device as long-term solution for maintenance the intra-ocular pressure, potentially reducing the number of surgeries (silicone oil exchanges) for the patient

Trial Locations

Locations (1)

University Hospitals Leuven (UZLeuven); 🇧🇪 Leuven, Vl-Brabant, Belgium