Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Registry Identifier | 2020-A00656-33 |
Not provided
Not provided
Not provided
Change in sponsor's strategy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LV-Visio-AMTRIX | Experimental | Sutureless amniotic membrane supported by a biological ring positioned by the investigator during patients' hospital visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LV-Visio-AMTRIX | Biological | Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm | Diameter assessed by centralized reading on photograph after fluorescein test | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003320 | Corneal Ulcer |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days |
| Stabilisation or decrease of pain evaluated on visual analog scale | VAS on 10 points from 0: no pain to 10: worst imaginable pain | 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days |
| D005128 |
| Eye Diseases |