Clinical trial NCT06450470: Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Official title: Multicenter, Randomized Study Evaluating the Use of a Non-sutured Sterile Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Progressive Keratoconus
Lead sponsor: TBF Genie Tissulaire
Sponsor class: INDUSTRY
First posted: 2024-06-10
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Man or woman between 18 and 65 years old.
* Indication for accelerated conventional crosslinking.
* Patient with progressive keratoconus (increase in Kmax of ≥ 0.5 diopters in 3 to 6 months or ≥ 1 diopter in 3 to 12 months with loss of 10 microns on minimum pachymetry in 3 to 12 month).
* Patient suffering from keratoconus with a compatible topographic form (Kmax ≥ 47.0 diopters (D) and difference inferior-superior of 1.5 D).
* Patient with a minimum corneal thickness greater than 400 microns.
* Informed and consenting patient.
* Patient physically and mentally capable of completing the post-operative pain assessment self-questionnaire.
* Patient having signed the informed consent of the French Ophthalmology Society for crosslinking.
* Patient affiliated to a social security system or beneficiary of such a system.

Exclusion Criteria:

* Woman without effective means of contraception, pregnant or breastfeeding.
* Patient who has already benefited from a crosslinking procedure on one of the eyes.
* Patient with a history of refractive surgery on one of the eyes.
* Patient with an intracorneal ring segment on one of the eyes.
* Patient suffering from a serious systemic pathology (autoimmune and/or immunodepressive)
* Patient with a psychiatric pathology.
* Patient on long-term analgesics and/or corticosteroids.
* Indication of crosslinking outside the classic protocol.
* Patient with central corneal opacity.
* Patient suffering from a severe dry eye syndrome or a neurotrophic keratitis.
* Patient with a history of ocular herpes.
* Patient with a history of ocular varicella-zoster virus infection.
* Patient with glaucoma.
* Patient treated with topical cyclosporine in the last 6 months.
* Patient deprived of liberty by a judicial or administrative decision.
* Patient subject to a legal protection measure or unable to express their consent.

Primary outcomes:
measure: 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)
timeFrame: Day 0 bedtime, Day 1 wake-up, Day 1 bedtime, Day 2 wake-up, Day 2 consultation
measure: Difference in analgesic consumption between patients treated with a therapeutic lens + amniotic membrane (experimental) and patients treated with a therapeutic lens alone (active comparator)
timeFrame: Day 0, Day 1, Day 2
Secondary outcomes:
measure: Difference in visual acuity between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)
timeFrame: Week 6
measure: Difference in corneal cicatrisation between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)
timeFrame: Day 2, (Day 7), Week 6
measure: Difference in corneal thickness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)
timeFrame: Week 6
measure: 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)
timeFrame: Week 6
measure: Difference in dryness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)
timeFrame: Week 6
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Assistance Publique - Hôpitaux de Marseille
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital National de la Vision des Quinze-Vingts
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
References: