Labial Mucosal Epithelium Grafting for Corneal Limbus Substitution
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
Earlier approaches for cornea reepithelization in patients with bilateral LSCD included allogeneic corneal limbus grafting from postmortem donor or livingrelated relatives with concomitant systemic immunosuppression (Cheung and Holland, 2017) and cultivated oral mucosal epithelial transplantation (COMET) (Nishida et al., 2004). The novel surgical technique for corneal re-epithelization were described by Liu et al. (2011) and Choe et al. (2019). In both clinical studies, the autologous labial mucosal epithelium graft was transplanted as a surrogate corneal limbus for purpose of treatment the LSCD. Authors reported positive outcomes in terms of anatomical success and corneal status improvement. The purpose of the study is to evaluate the feasibility of the novel surgical intervention in clinical use.
Eligibility Criteria
Inclusion Criteria: * Man or woman 18 years and older. * Signed informed consent, given by the participant or his/her legal representative. * Ability to understand Russian spoken and written language. * Sanitated oral cavity. * Bilateral limbal stem cell deficiency diagnosed by two or more symptoms during slit-lamp examination: corneal conjunctivalization, absence of palisades of Vogt, superficial corneal neovascularization, recurrent or persistent corneal epithelium erosion. * Bilateral limbal stem cell deficiency non-immunogenic etiology (burns, irradiation, contact lens related, etc.). * Best-corrected visual acuity less than 0.3 (6/18 Snellen chart) * Intraocular pressure in normal range. * Schirmer's test I more than 5 mm. Exclusion Criteria: * Inability to give signed informed consent. * Age under 18 years. * Pregnancy and/or breastfeeding. * Hormonal contraceptives intake. * History of allergic reactions to antibiotics, glucocorticosteroids, remedies for treatment dry eye syndro