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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03390244
Other study ID # S59809
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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