Status:
TERMINATED
Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Treatment-Resistant Keratitis
Lead Sponsor:
TBF Genie Tissulaire
Conditions:
Keratitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this open, mono center trial is to assess the impact of the use of an amniotic membrane on the healing of a keratitis resistant to medical treatment.
Eligibility Criteria
Inclusion
- Male or female; age between 18 and 65 years.
- Patient with non-infectious keratitis resistant to medical treatment for more than 15 days or recurrent after healing treatment.
- Patient with quantitative and qualitative score for inflammatory ocular signs \> 20.
- Patient with Oxford grade \> 2.
- Informed and consenting patient with a relative or friend available to instill eye drops if necessary.
- Patient affiliated to a social security system or beneficiary of such a system.
Exclusion
- Patient with active infectious keratitis (bacterial, parasitic or viral).
- Patient with allergy to Oxybuprocaine or Tetracaine eye drops, to ester type local anesthetics and to fluorescein.
- Current contact lens wear, including scleral lenses.
- NSAID eye drops and any drops containing preservatives.
- Antibiotic, anti-viral, anti-parasitic eye drops.
- Patient with identified causes for the keratitis for which discontinuation of medical treatment beneficial.
- Ocular surgery in the 3 months preceding the inclusion in the study.
- Monophtalmic patient.
- Person deprived of liberty by a judicial or administrative decision.
- Adult subjected to a legal protection measure or unable to express his/her consent.
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05250583
Start Date
June 29 2020
End Date
January 7 2021
Last Update
November 14 2024
Active Locations (1)
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1
CHU de Saint-Etienne Hôpital Nord
Saint-Priest-en-Jarez, France, 42270