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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant.
Institut Curie
Paris, France
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
Time frame: Through study completion (6 months)
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
Time frame: 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 frame: Time of investigational product surgical implantation (Day 0)
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