Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation I… (NCT05236049) | Clinical Trial Compass
CompletedPhase 1
Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant
France12 participantsStarted 2019-07-01
Plain-language 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 patients who underwent enucleation due to an eye malignant tumor resection.
Who can participate
Age range45 Years – 85 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant