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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
116
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.
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.
CHU de Brest
Brest, France
RECRUITINGHospices Civils de Lyon
Lyon, France
RECRUITINGAssistance Publique - Hôpitaux de Marseille
Marseille, France
RECRUITINGCHU de Montpellier
Montpellier, France
RECRUITINGCHU de Nantes
Nantes, France
NOT_YET_RECRUITINGHôpital National de la Vision des Quinze-Vingts
Paris, France
RECRUITINGCHU de Saint-Etienne
Saint-Priest-en-Jarez, France
RECRUITINGHôpitaux Universitaires de Strasbourg
Strasbourg, France
RECRUITINGCHU de Toulouse
Toulouse, France
RECRUITINGDifference 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)
Time frame: 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
Time frame: Day 0, Day 1, Day 2
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
Time frame: Week 6
Difference in corneal cicatrisation between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)
Healing evaluated under slit lamp by fluorescein examination
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: Week 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.