Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2 participants
INTERVENTIONAL
2017-05-02
2020-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FCVB Implant
All subjects in this study are in the experimental treatment arm and will receive the FCVB implant
Foldable Capsular Vitreous Body Implant
Vitrectomy augmented with the implantation of the FCVB implant
Interventions
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Foldable Capsular Vitreous Body Implant
Vitrectomy augmented with the implantation of the FCVB implant
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Prof. Dr. Peter Stalmans
Head of Clinic
Principal Investigators
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Peter Stalmans, MD Phd
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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University Hospitals Leuven (UZLeuven)
Leuven, Vl-Brabant, Belgium
Countries
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Other Identifiers
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S59809
Identifier Type: -
Identifier Source: org_study_id
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