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

Study Overview
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Brief Summary
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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.

Official Title
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Use of a Double Amniotic Membrane Inserted in a Ring of Umbilical Vessels With Wharton's Jelly, Tissues Treated by the AMTRIX Process, in the Treatment of Keratitis Resisting Healing Medical Treatment

Conditions
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Keratitis

Intervention / Treatment
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* Biological: LV-Visio-AMTRIX


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LV-Visio-AMTRIX<br>Sutureless amniotic membrane supported by a biological ring. | Biological: LV-Visio-AMTRIX<br>* Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratitis healing within 15 days after the beginning of the treatment | Keratitis observed under slit lamp using fluorescein instillation. Keratitis considered healed if epithelialization of more than 50% and/or Oxford < grade 2 | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stable or decreased score for inflammatory and clinical signs of the ocular surface | Composite score for inflammatory and clinical signs of the ocular surface on 66 points. Duration and intensity are evaluated for secretion, dry eyes, tearing, foreign body sensation, fluctuating vision, photophobia, burning sensation and lids edema. Duration is evaluated from a scale from 0: never to 4: all the time. Intensity is evaluated from a scale from 0: slight to 2: severe. Localization and intensity are evaluated for conjunctival edema, conjunctival redness and neovascularization. Localization is evaluated on a scale from 0: no reaction to 4: reaction present in the whole eye. | 1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days | 
| Stabilisation or decrease of pain evaluated on visual analog scale | Visual Analog Scale (VAS) on 10 points from 0: no pain to 10: worst imaginable pain | 1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days | 
| Preservation of epithelialization | Preservation of new epithelialization evaluated under slit lamp using fluorescein instillation and Oxford grading system | 15 days, 30 days, 45 days | 
| Change in eye dryness | Eye dryness evaluated by the Ocular Surface Disease Index (OSDI) (0-12 = normal; 13-22 = mild dry eye; 23-32 = moderate dry eye; >33 = severe dry eye) | 15 days, 30 days, 45 days |