Vitreoretinal SurgeryFCVBNCT03390244
Foldable Capsular Vitreous Body Implantation Study
A study testing Foldable Capsular Vitreous Body Implant in people with Vitreoretinal Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreoretinal Surgery
- What is being tested?
- Foldable Capsular Vitreous Body Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteBelgium
- Study dates
- 2 May 2017to 5 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Belgium1 site
University Hospitals Leuven (UZLeuven)
Leuven, Vl-Brabant, B3000
About this study
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.
- Conditions
- Vitreoretinal Surgery
- Being tested
- Foldable Capsular Vitreous Body Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foldable Capsular Vitreous Body ImplantDevice
Vitrectomy augmented with the implantation of the FCVB implant
| Study group | Role | What they receive |
|---|---|---|
| FCVB Implant | Experimental | All subjects in this study are in the experimental treatment arm and will receive the FCVB implant Receives: Device: Foldable Capsular Vitreous Body Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start2 May 2017
- Primary completion2 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreoretinal SurgeryStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Peter Stalmans, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Peter Stalmans, MD Phd, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390244
- Sponsor's protocol ID
- S59809
- Acronym
- FCVB
- Status last verified
- Aug 2022
- First submitted
- 8 Dec 2016
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foldable Capsular Vitreous Body Implantation Study
- ClinicalTrials.gov ID
- NCT03390244
- Acronym / sponsor ID
- FCVB / S59809
- Conditions
- Vitreoretinal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 2 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FCVB Implant | Experimental | Device: Foldable Capsular Vitreous Body ImplantAll subjects in this study are in the experimental treatment arm and will receive the FCVB implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foldable Capsular Vitreous Body ImplantVitrectomy augmented with the implantation of the FCVB implant | Device | FCVB Implant |
Primary outcome
Intra-ocular pressure
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Stalmans, MD Phd principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foldable Capsular Vitreous Body Implant in people with Vitreoretinal Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-ocular pressure (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.