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NCT Number: NCT06450470

Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Brest, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

    Time frame: Day 0 bedtime, Day 1 wake-up, Day 1 bedtime, Day 2 wake-up, Day 2 consultation

    Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)

  2. Difference in analgesic consumption between patients treated with a therapeutic lens + amniotic membrane (experimental) and patients treated with a therapeutic lens alone (active comparator)

    Time frame: Day 0, Day 1, Day 2

    Amount in grams of analgesic consumed per day

Secondary outcomes

  1. Difference in visual acuity between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)

    Time frame: Week 6

    Determination of logMAR values of best corrected visual acuity

  2. Difference in corneal cicatrisation between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)

    Time frame: Day 2, (Day 7), Week 6

    Healing evaluated under slit lamp by fluorescein examination

  3. Difference in corneal thickness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)

    Time frame: Week 6

    Corneal thickness evaluated by anterior segment optical coherence tomography.

  4. 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)

    Time frame: Week 6

    Topographic parameters (Kmax, inferior-superior) evaluated by corneal topography

  5. Difference in dryness between eyes treated with therapeutic lens + amniotic membrane (experimental) and eyes treated with therapeutic lens alone (active comparator)

    Time frame: Week 6

    Dry eye and effect on vision evaluated between 0 (no disability) and 100 (greater disability) using Ocular Surface Disease Index (OSDI)

Study contacts

Contact information is provided by the study sponsor or research team.

Justine BOSC, MSc

CONTACT

[email protected]

4 72 68 69 11 ext. +33

Laurence BARNOUIN, MD

CONTACT

[email protected]

0472686909 ext. +33

Sponsors and collaborators

Lead sponsor

TBF Genie Tissulaire

Industry

Registry information

Official study title

Multicenter, Randomized Study Evaluating the Use of a Non-sutured Sterile Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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