Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Treatment-Resistant Keratitis

TBF Genie Tissulaire

Status and phase

Terminated

Phase 2

Conditions

Keratitis

Treatments

Biological: LV-Visio-AMTRIX

Study type

Interventional

Funder types

Industry

Identifiers

NCT05250583

L-Visio-AMTRIX-TBF3

2019-A03144-53 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.