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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01738-47 | Registry Identifier | IDRCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SclerFIX | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SclerFIX | Biological | Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in support of intraocular implant. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie | Paris | 75005 | France |
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| ID | Term |
|---|---|
| D005134 | Eye Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005128 | Eye Diseases |
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| 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) |