Foldable Capsular Vitreous Body Implantation Study (FCVB)

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.

Study Overview

• Status: Completed
• Conditions: Vitreoretinal Surgery
• Intervention / Treatment: Device: Foldable Capsular Vitreous Body Implant

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vl-Brabant
    • Leuven, Vl-Brabant, Belgium, B3000
      • University Hospitals Leuven (UZLeuven)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FCVB Implant; All subjects in this study are in the experimental treatment arm and will receive the FCVB implant	Device: Foldable Capsular Vitreous Body Implant; Vitrectomy augmented with the implantation of the FCVB implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-ocular pressure	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	3 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2017
• Primary Completion (ACTUAL): May 2, 2020
• Study Completion (ACTUAL): May 5, 2020

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (ACTUAL): January 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: S59809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No