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FCVB: Foldable Capsular Vitreous Body Implantation Study

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT03390244
Collaborator
(none)
2
Enrollment
1
Location
1
Arm
36.1
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Foldable Capsular Vitreous Body Implant
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Foldable Capsular Vitreous Body Implantation Study
Actual Study Start Date :
May 2, 2017
Actual Primary Completion Date :
May 2, 2020
Actual Study Completion Date :
May 5, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Leuven (UZLeuven) Leuven Vl-Brabant Belgium B3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

  • Principal Investigator: Peter Stalmans, MD Phd, UZ Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. Peter Stalmans, Head of Clinic, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT03390244
Other Study ID Numbers:
  • S59809
First Posted:
Jan 4, 2018
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 18, 2022