Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation I… (NCT05236049) | Clinical Trial Compass
CompletedPhase 1
Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant
France12 participantsStarted 2019-07-01
Plain-language 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.
Who can participate
Age range
45 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of complications and adverse events related to SclerFIX set-up as replacement of sclera graft for support of enucleation implant