Corneal Ulcer, Persistent Corneal Epithelial Defect
Conditions
Brief summary
The purpose of this open, multicenter pilot trial is to assess the impact of the use of an amniotic membrane on the healing of a persistent epithelial lesion or of a corneal ulcer.
Interventions
BIOLOGICALLV-Visio-AMTRIX
Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit
Sponsors
TBF Genie Tissulaire
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between 18 and 80 years old * Stage 2 (persistent epithelial lesion : LEP) or stage 3 (corneal ulcer) trophic ulcer affecting only one eye. Patient whose contralateral eye is affected by stage 1 neurotrophic keratitis may also be included * Two or more weeks old LEP or corneal ulcer refractory to one or more conventional nonsurgical therapies * Absence of objective evidence of improvement of the epithelial ulceration or corneal ulcer within 2 weeks prior to study inclusion * Failure of amniotic membrane treatment of the trophic ulcer: failure by absence of healing a few day after overlay treatment or 15 days after inlay grafting * Patient able to understand French language * Informed and consenting patient * Patient affiliated to a social security system or beneficiary of such a system
Exclusion criteria
* Pregnant or breastfeeding patient or without contraception for non-menopausal women * Active infectious ulcer * Preperforating ulcer or ulcer that has reached the posterior 1/3 of the storm * 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 * Patients with identified causes of the ulcer for which medical treatment without preservatives or other healing treatment is beneficial * Ocular surgery for other pathology than the trophic ulcer in the 3 months preceding the inclusion in the study * Ophthalmologic pathology requiring daily eye drops * Monophtalmic patients * Persons deprived of liberty by a judicial or administrative decision * Adults who are subject to a legal protection measure or who are unable to express their consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm | 15 days | Diameter assessed by centralized reading on photograph after fluorescein test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of the visual acuity evaluated by Monoyer chart | 30 days, 45 days | — |
| Stable or decreased score for inflammatory and clinical signs of the ocular surface | 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days | 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. |
| Stabilisation or decrease of pain evaluated on visual analog scale | 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days | VAS on 10 points from 0: no pain to 10: worst imaginable pain |
Outcome results
None listed