Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant

Study Overview
=================
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 patients who underwent enucleation due to an eye malignant tumor resection.

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.

Official Title
-----------------
Evaluation of Safety and Efficacy of Wrapping Orbital Implant by SclerFIX Product After Eye Enucleation

Conditions
-----------------
Enucleated; Eye, Eye Cancer

Intervention / Treatment
-----------------
* Biological: SclerFIX


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SclerFIX<br>Strip of umbilical cord lining membrane allograft wrapped around the bioceramic enucleation implant. The assembly is placed inside the void orbital cavity and the muscles are sutured to the SclerFIX strips. | Biological: SclerFIX<br>* Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant | Evaluation of SclerFIX tolerance by physical examination of the patient: clean scar; absence of redness, edema, ulcer, granuloma and cystic lesion; absence of signs of protrusion and inflammation | Through study completion (6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of integration of SclerFIX set-up in the orbital cavity with muscles attachment allowing enucleation implant mobility | Evaluation by physical examination by the surgeon of the set-up assembly and its maintenance over time with insertion of oculomotor muscles, integration of these latter, and maintenance of the movement of the implant | 7 days, 15 days, 1 month, 3 months, 6 months | 
| Evaluation of surgical wrapping and attachment with muscles | Surgeon assessment on completeness and difficulty of oculomotor muscles insertion at the time of product implantation (Day 0) | Time of investigational product surgical implantation (Day 0) |