Vitreoretinal Surgery
Conditions
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.
Interventions
DEVICEFoldable Capsular Vitreous Body Implant
Vitrectomy augmented with the implantation of the FCVB implant
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed