Status:
COMPLETED
Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant
Lead Sponsor:
TBF Genie Tissulaire
Conditions:
Enucleated; Eye
Eye Cancer
Eligibility:
All Genders
45-85 years
Phase:
PHASE1
Brief Summary
The purpose of this open, monocenter pilot trial is to evaluate the tolerance of the SclerFIX product, an allograft of umbilical cord lining membrane, in the reinforcement of ocular implants in patien...
Detailed Description
As scleral graft is forbidden in France, it cannot be used for support of enucleation implants. This study investigational product, SclerFIX, was developed to substitute scleral grafts in those cases.
Eligibility Criteria
Inclusion
- Men or women between 45 and 85 years old, presenting an enucleation caused by malignant tumor resection.
- Oncological treatment compatibility with enucleation and intra-orbital implant.
- Surgery requiring the placement of an enucleation implant.
- Persistence of the oculomotor muscles allowing their insertion into the tissue.
- Patient with social security coverage.
- Consenting and informed patient.
Exclusion
- Pregnant or breast-feeding women: women of childbearing age were asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method.
- Patient presenting an infectious risk (neutropenia, active local infection, immunodeficiency).
- Patient with autoimmune disease.
- Proton-therapy / radiotherapy of the eye before healing.
- Patient with oculomotor muscles invasion or non-attachment of these muscles.
- Allergy to contrast agents used in radiology.
- Patient under legal guardianship.
- Patient not benefiting from the social security cover.
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05236049
Start Date
July 1 2019
End Date
April 27 2022
Last Update
May 1 2023
Active Locations (1)
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1
Institut Curie
Paris, France, 75005