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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00004-43 | Registry Identifier | IDRCB |
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Crosslinking is a therapeutic technique used to increase the rigidity of the cornea in order to slow or stop progression of keratoconus. The main complication of the treatment of keratoconus by crosslinking is postoperative pain due to the removal of the corneal epithelium. Currently, the management of pain is done through the administration of artificial tears and paracetamol. The amniotic membrane is a biological tissue used in ophthalmology to treat injuries of the surface of the eye. It has healing and analgesic properties.
The objective of this multicenter randomized study is to evaluate the benefit of placing an amniotic membrane on the eye post-crosslinking to reduce pain and promote corneal healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic lens alone | Active Comparator |
| |
| Therapeutic lens + amniotic membrane (Visio-AMTRIX) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic lens alone | Device | Therapeutic lens will be apposed on the patient's eye after crosslinking. Therapeutic lens will be maintained without interruption until the first postoperative visit (Day 2) when it will be removed by the investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the level of ocular pain experienced by patients treated with therapeutic lens + amniotic membrane (experimental) and by patients treated with therapeutic lens alone (active comparator) | Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS) | Day 0 bedtime, Day 1 wake-up, Day 1 bedtime, Day 2 wake-up, Day 2 consultation |
| Difference in analgesic consumption between patients treated with a therapeutic lens + amniotic membrane (experimental) and patients treated with a therapeutic lens alone (active comparator) | Amount in grams of analgesic consumed per day | Day 0, Day 1, Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in visual acuity between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator) | Determination of logMAR values of best corrected visual acuity | Week 6 |
| Difference in corneal cicatrisation between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurence BARNOUIN, MD | Contact | 0472686909 | +33 | laurence.barnouin@tbf-lab.com |
| Justine BOSC, MSc | Contact | 4 72 68 69 11 | +33 | justine.bosc@tbf-lab.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Brest | Recruiting | Brest | 29609 | France |
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| Therapeutic lens + amniotic membrane (Visio-AMTRIX) | Combination Product | Amniotic membrane (Visio-AMTRIX) will be apposed under therapeutic lens on the patient's eye after crosslinking. Amniotic membrane and therapeutic lens will be maintained without interruption until the first postoperative visit (Day 2) when it will be removed by the investigator. |
|
Healing evaluated under slit lamp by fluorescein examination |
| Day 2, (Day 7), Week 6 |
| Difference in corneal thickness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator) | Corneal thickness evaluated by anterior segment optical coherence tomography. | Week 6 |
| Difference in topographic parameters (Kmax, inferior-superior) between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator) | Topographic parameters (Kmax, inferior-superior) evaluated by corneal topography | Week 6 |
| Difference in dryness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator) | Dry eye and effect on vision evaluated between 0 (no disability) and 100 (greater disability) using Ocular Surface Disease Index (OSDI) | Week 6 |
| Hospices Civils de Lyon | Recruiting | Lyon | 69003 | France |
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| Assistance Publique - Hôpitaux de Marseille | Recruiting | Marseille | 13005 | France |
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| CHU de Montpellier | Recruiting | Montpellier | 34295 | France |
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| CHU de Nantes | Not yet recruiting | Nantes | 44000 | France |
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| Hôpital National de la Vision des Quinze-Vingts | Recruiting | Paris | 75012 | France |
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| CHU de Saint-Etienne | Recruiting | Saint-Priest-en-Jarez | 42270 | France |
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| Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67000 | France |
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| CHU de Toulouse | Recruiting | Toulouse | 31300 | France |
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