Abstract
BackgroundThe sparsity of established tools for the grading of limbal stem cell deficiency hinder objective assessments of the clinical outcome of cultivated limbal epithelial cell transplantation. To advance towards the development of standards for the comparison of the outcomes of these bio-surgical protocols we have now applied a battery of recognized objective and patient-declared subjective outcome criteria to the autologous modality of cultivated limbal epithelial cell transplantation.MethodsThe prospective study involved ten patients (M/F = 9/1; mean age = 42.1 years) displaying overt unilateral limbal stem cell deficiency complying with the inclusion criteria described in Methods. Limbal biopsies were obtained from the contralateral eye and their outgrowths after 2-week cultures were transplanted on the affected eye after pannus resection. Outcomes were followed up for 12 months. The objective tests were scores for best-corrected visual acuity (BCVA); using the LogMAR scale, a multiparametric ocular surface score (OSS), and the Schirmer’s test. Subjective scores were based on patient answers to a) perception of visual improvement/pain; b) the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ 25); and c) the 12-item Ocular Surface Disease Index Questionnaire (OSDI). All procedures were performed under good manufacture practices using solely xeno-free reagents. In all cases, a single biopsy was divided into two pieces and they were expanded in order to prevent outgrowth failure. In 5 patients, both biopsies generated healthy culture sheet. In those cases the lesser outgrowth were used for immune-histological characterization.ResultsThe experimental parallel outgrowth samples showed a similar percent of p63α+ cells. PreOp and 12-month PostOp BCVAs and OSSs were, respectively, 1.15 ± 0.70; 0.21 ± 0.13 and 7.40 ± 2.01; 2,30 ± 1.30, (p < 0.05). Patient’s responses to all three question sets except ocular pain were consistent with significant improvement (p < 0.05).ConclusionObjective clinical metrics demonstrate that in patients with limbal stem cell deficiency, cultivated limbal epithelial cell transplantation improves vision and ocular surface health and subjective visual perceptions.
Highlights
The sparsity of established tools for the grading of limbal stem cell deficiency hinder objective assessments of the clinical outcome of cultivated limbal epithelial cell transplantation
Results are presented as the logarithm of the minimum angle of resolution (LogMAR) scale; the 0 and 1 LogMAR values correspond to 20/20 and 20/200 Best-corrected visual acuity (BCVA) in the popularly known Snellen scale, respectively
All contralateral limbal donor eyes showed no change in visual acuity during the follow-up period or resulted in reports of pain or discomfort by the subjects
Summary
The sparsity of established tools for the grading of limbal stem cell deficiency hinder objective assessments of the clinical outcome of cultivated limbal epithelial cell transplantation. Limbal stem cell deficiency (LSCD) is a condition induced by a number of diverse factors, ranging from genetic abnormalities to accidental limbal injuries. It develops when the epithelial stem and precursor cell systems of the limbal zone undergo numerical or functional degradation, thereby compromising the regenerative capacity of the corneal epithelium [1,2,3,4,5]. To contribute to the development of such standards, we have subjected our clinical CLET work, completed under the guidelines for good laboratory practices (GLP) to a battery of recognized objective and patient-declared subjective outcome criteria
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