Overview
The purpose of this open, multicenter phase II trial is to confirm the tolerance and evaluate the efficacy of the SclerFIX product, an allograft of umbilical cord lining membrane, in reinforcement of scleral thinning in patients who underwent eye tumor exeresis.
Description
As scleral graft is forbidden in France, it cannot be used to reinforce the sclera. This study investigational product, SclerFIX, was developed to substitute scleral grafts.
Eligibility
Inclusion Criteria:
- Male or female, aged 18 to 80 years.
- Patients with risk of perforation or deep loss of substance during surgical removal of a tumor of the ocular surface.
- Patient with loss of substance < 3cm2.
- Patient able to understand, sign and date the informed consent form.
- Patient who is a member or a beneficiary of a national health insurance plan.
Exclusion Criteria:
- Pregnant or breastfeeding woman or woman of childbearing age without effective contraception.
- Patients with uncontrolled infectious risk.
- Patient with an autoimmune disease.
- Person deprived of liberty by a judicial or administrative decision.
- Person under forced psychiatric care.
- Person admitted to a health or social institution for purposes other than the research.
- Adult subjected to a legal protection measure or unable to express his / her consent.