Clinical trial · Interventional
Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant
Evaluation of Safety and Efficacy of Wrapping Orbital Implant by SclerFIX Product After Eye Enucleation
NCT05236049CI-TRIAL-00066065completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Enucleated; Eye | — | UNRESOLVED | — |
| Eye Cancer | Malignant Eye Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SclerFIX | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SclerFIX
- description
- 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.
- interventionNames
- Biological: SclerFIX
Primary outcomes (1)
- measure
- Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant
- timeFrame
- Through study completion (6 months)
- description
- 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
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.