Foldable Capsular Vitreous Body Implantation Study

Vitreoretinal Surgery Clinical Trial

— FCVB  

Official title:

Foldable Capsular Vitreous Body Implantation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390244
• Other study ID #: S59809
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: May 5, 2020

Study information

• Verified date: August 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 5, 2020
• Est. primary completion date: May 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitreoretinal Surgery

Intervention

Device:
• Foldable Capsular Vitreous Body Implant
Vitrectomy augmented with the implantation of the FCVB implant

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven (UZLeuven)	Leuven	Vl-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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