Eye Injury Clinical Trial
Official title:
Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease
The aim of the study is to assess if transplantation of cultivated corneal epithelial stem cells could restore vision in patients with severe ocular surface disorder with a favourable safety profile that warrants further comparative study.
Objectives:
Efficacy:
To determine the efficacy of cultivated corneal epithelial stem cells as a treatment for
patients with severe ocular surface disorder.
The corneal limbal epithelial stem cell transplant (CLET) successful outcome will be
measured by improvement of vision, maintenance of corneal re-epithelisation with absence of
recurrence of surface disease and subjective improvement of symptoms.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment