Prospective evaluation of the safety and efficacy of Cultivated Oral Mucosal Epithelial Transplantation (COMET) for fornix reconstruction in cases of severe ocular surface disease

Abstract

Purpose : Since 2002, cultivated oral mucosal epithelial transplantation (COMET) has been used for ocular surface reconstruction in cases of severe ocular surface disease. The purpose of this prospective, interventional clinical study was to examine the safety and efficacy of COMET for fornix reconstruction in cases of severe ocular surface disease.

Methods : This prospective clinical study involved patients with severe ocular surface disease (i.e., Stevens-Johnson syndrome: n = 5 eyes; ocular cicatricial pemphigoid: n =1 eye) with a 50% or greater adhesion of either the upper or lower conjunctival fornix that underwent COMET for fornix reconstruction at the Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan between January 2014 and February 2017. Surgical outcomes were defined as changes in each score between at pre surgery (baseline) and at 24-weeks postoperative, with the primary outcome being the fornix shortening score. Secondary outcomes were the Ocular Surface Grading Score (OSGS), the best-corrected visual acuity (BCVA), the results of the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25), and adverse events. The changes in each score from at baseline were analyzed using the one-sample t-test.

Results : From baseline to 24-weeks postoperative, the fornix shortening score significantly improved from 4.7 (median: 4.5; range: 3-6) to 1.2 (median: 0; range: 0-3) (p= 0.001) and the OSGS significantly improved from 15.2 (median: 14.5; range: 11-20) to 6.2 (median: 5.0; range: 2-14) (p=0.0052), yet no significant difference in BCVA was observed. In the NEI VFQ-25 findings, 9 of the 12 subscales improved, with significant differences observed in “General vision” and “Ocular pain” (p= 0.0104, 0.040, respectively). No complications associated with COMET were observed post surgery.

Conclusions : Our findings clearly demonstrate the safety and efficacy of COMET for fornix reconstruction in cases of severe ocular surface disease.

This is a 2021 ARVO Annual Meeting abstract.