Abstract
Purpose:
To evaluate the efficacy of cultivated limbal epithelial transplantation (CLET), performed under the new European regulations, for the management of ocular surface failure due to limbal epithelial stem cell deficiency syndrome (LSCD).
Methods:
CLET was performed in 20 eyes (19 patients) suffering LSCD, autologous in 11 (55%) cases and allogenic in 9 (45%) eyes. In vitro expanded limbal stem cells (in a clean room facility following GMP rules) were transplanted on amniotic membrane after superficial keratectomy. LSCD etiologies were: 7 chemical burns, 5 iatrogenic (post-multiple surgeries), 4 immune-based inflammation (Stevens Johnson’s syndrome and ocular pemphigoid), 2 post-chronic infections, and 2 congenital aniridia. Outcome end-points, evaluated after one year follow-up were: 1] Primary: 1.1) improvement on visual-related aspects of quality of life (National Eye Institute Visual Functioning 25 questionnaire, NEI-VF25) and symptoms (OSDI questionnaire); and 1.2) presence of a more corneal-like phenotype in central cornea evaluated clinically (absence of epithelial breakdown and improvement of epithelial opacity) and by in vivo confocal microscopy (CM); 2] Secondary: 2.1) visual acuity improvement ≥ 2 lines; 2.2) amelioration of superficial vascularization.
Results:
The two primary outcomes were achieved by 17 (85%) eyes; of these 17 eyes, 12 (60% of the total number) also gained vision, 3 eyes underwent successful keratoplasty, and 2 eyes had no previous potential to gain vision with no further interventions. NEI-VF25 questionnaire improved from 62.84+22.39 to 70.56+19.57 (p=0.0011) and OSDI decreased from 47.91+25.97 to 36.12+25.16 (p=0.0010). Of the 3 failed eyes, 2 had autologous CLET (chemical burns) and 1 eye had allogeneic CLET (Stevens Johnson’s). By CM, central corneal epithelium was cornea-like phenotype in 18 eyes (13 cornea phenotype, 5 mixed phenotype) and it was conjunctival-like epithelium in 2 eyes. Neovascularization was slightly affected and reduced in only 5 cases.
Conclusions:
CLET significantly improved the quality of corneal epithelium in patients with LSCD. The subsequent improvement in symptoms increased quality of life. These results confirm others stating that CLET is an alternative for ocular surface failure due to LSCD although still insufficient to eliminate corneal vascularization.
Keywords: 482 cornea: epithelium •
687 regeneration