Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers (NCT05172349) | Clinical Trial Compass
WithdrawnPhase 2
Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic Ulcers
Stopped: Change in sponsor's strategy
0Started 2022-04
Plain-language summary
The purpose of this open, multicenter pilot trial is to assess the impact of the use of an amniotic membrane on the healing of a persistent epithelial lesion or of a corneal ulcer.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female between 18 and 80 years old
* Stage 2 (persistent epithelial lesion : LEP) or stage 3 (corneal ulcer) trophic ulcer affecting only one eye. Patient whose contralateral eye is affected by stage 1 neurotrophic keratitis may also be included
* Two or more weeks old LEP or corneal ulcer refractory to one or more conventional nonsurgical therapies
* Absence of objective evidence of improvement of the epithelial ulceration or corneal ulcer within 2 weeks prior to study inclusion
* Failure of amniotic membrane treatment of the trophic ulcer: failure by absence of healing a few day after overlay treatment or 15 days after inlay grafting
* Patient able to understand French language
* Informed and consenting patient
* Patient affiliated to a social security system or beneficiary of such a system
Exclusion Criteria:
* Pregnant or breastfeeding patient or without contraception for non-menopausal women
* Active infectious ulcer
* Preperforating ulcer or ulcer that has reached the posterior 1/3 of the storm
* Allergy to Oxybuprocaine or Tetracaine eye drops, to ester type local anesthetics and to fluorescein
* Current contact lens wear, including scleral lenses
* NSAID eye drops and any drops containing preservatives
* Antibiotic, anti-viral, anti-parasitic eye drops
* Patients with identified causes of the ulcer for which medical treatment without preservatives or other healing treatment is beneficial
* Ocular surgery for other pathology than the tr…
What they're measuring
1
Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm