Status:
COMPLETED
Foldable Capsular Vitreous Body Implantation Study
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Vitreoretinal Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2020
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03390244
Start Date
May 2 2017
End Date
May 5 2020
Last Update
August 18 2022
Active Locations (1)
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1
University Hospitals Leuven (UZLeuven)
Leuven, Vl-Brabant, Belgium, B3000