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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A03144-53 | Other Identifier | IDRCB |
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Low accrual rate
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LV-Visio-AMTRIX | Experimental | Sutureless amniotic membrane supported by a biological ring. |
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| 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 |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne Hôpital Nord | Saint-Priest-en-Jarez | 42270 | France |
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| ID | Term |
|---|---|
| D007634 | Keratitis |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| 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 |