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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-29

Study Completion Date

2021-01-07

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.

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Detailed Description

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Conditions

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Keratitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LV-Visio-AMTRIX

Sutureless amniotic membrane supported by a biological ring.

Group Type EXPERIMENTAL

LV-Visio-AMTRIX

Intervention Type BIOLOGICAL

Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit

Interventions

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LV-Visio-AMTRIX

Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No