Foldable Capsular Vitreous Body Implantation Study (FCVB)

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Vitreoretinal Surgery

Treatments: Device: Foldable Capsular Vitreous Body Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT03390244

S59809

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

FCVB Implant

Experimental group

Description:

All subjects in this study are in the experimental treatment arm and will receive the FCVB implant

Treatment:

Device: Foldable Capsular Vitreous Body Implant