A study of wrapping orbital Implant by SclerFIX product after eye enucleation

TBF Genie Tissulaire is recruiting patients for the clinical trial of Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant.

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.

The researchers plan that July 12, 2019 will be the study start date. The indicative completion of the clinical trial will be expected in July 2022.

Among primary outcome measures are the Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant and 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.

The study will take place at the Institut Curie, Paris, France.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05236049.