A Phase 2 interventional study of LV-Visio-AMTRIX in Corneal Ulcer and Persistent Corneal Epithelial Defect, sponsored by TBF Genie Tissulaire. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by TBF Genie Tissulaire · Phase 2, Interventional, and Treatment
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.
57 studies on the registry are indexed under Corneal Ulcer; 8 are open to participants now.
Browse Corneal Ulcer studies →TBF Genie Tissulaire is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sutureless amniotic membrane supported by a biological ring positioned by the investigator during patients' hospital visits.
Biological: LV-Visio-AMTRIX
Chemically-treated, viro-inactivated, freeze-dried and irradiated allograft placed by the investigator during patients' hospital visit
Largest diameter of persistent epithelial lesion area or corneal ulcer under 0.5 mm
Diameter assessed by centralized reading on photograph after fluorescein test
Time frame: 15 days
Recovery of the visual acuity evaluated by Monoyer chart
Time frame: 30 days, 45 days
Stable or decreased score for inflammatory and clinical signs of the ocular surface
Composite score for inflammatory and clinical signs of the ocular surface on 66 points. Duration and intensity are evaluated for secretion, dry eyes, tearing, foreign body sensation, fluctuating vision, photophobia, burning sensation and lids edema. Duration is evaluated from a scale from 0: never to 4: all the time. Intensity is evaluated from a scale from 0: slight to 2: severe. Localization and intensity are evaluated for conjunctival edema, conjunctival redness and neovascularization. Localization is evaluated on a scale from 0: no reaction to 4: reaction present in the whole eye.
Time frame: 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days
Stabilisation or decrease of pain evaluated on visual analog scale
VAS on 10 points from 0: no pain to 10: worst imaginable pain
Time frame: 2 days, 4 days, 7 days, 10 days, 15 days, 30 days, 45 days
No study locations are listed for this record.
This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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TBF Genie Tissulaire