Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Ophthalmology. 2013 Jan;120(1):193-200. doi: 10.1016/j.ophtha.2012.07.053. Epub 2012 Oct 16.
To report the effectiveness, disease-specific outcomes, and safety of cultivated oral mucosal epithelial sheet transplantation (COMET), with the primary objective of visual improvement.
Noncomparative, retrospective, interventional case series.
This study involved 46 eyes in 40 patients with complete limbal stem cell deficiency (LSCD) who underwent COMET for visual improvement. These LSCD disorders fell into the following 4 categories: Stevens-Johnson syndrome (SJS; 21 eyes), ocular cicatricial pemphigoid (OCP; 10 eyes), thermal or chemical injury (7 eyes), or other diseases (8 eyes).
Best-corrected visual acuity (BCVA) and ocular surface grading score were examined before surgery; at the 4th, 12th, and 24th postoperative week; and at the last follow-up. Data on COMET-related adverse events and postoperative management were collected. The outcomes in each disease category were evaluated separately.
The primary outcome was the change in median logarithm of the minimum angle of resolution (logMAR) BCVA at the 24th postoperative week. The secondary outcome was the ocular surface grading score.
Median logMAR BCVA at baseline was 2.40 (range, 1.10 to 3.00). In SJS, logMAR BCVA improved significantly during the 24 weeks after surgery. In contrast, the BCVA in OCP was improved significantly only at the 4th postoperative week. In 6 of the 7 thermal or chemical injury cases, logMAR BCVA improved after planned penetrating keratoplasty or deep lamellar keratoplasty. Grading scores of ocular surface abnormalities improved in all categories. Of 31 patients with vision loss (logMAR BCVA, >2) at baseline, COMET produced improvement (logMAR BCVA, ≤2) in 15 patients (48%). Visual improvement was maintained with long-term follow-up (median, 28.7 months). Multivariate stepwise logistic regression analysis showed that corneal neovascularization and symblepharon were correlated significantly with logMAR BCVA improvement at the 24th postoperative week (P=0.0023 and P=0.0173, respectively). Although postoperative persistent epithelial defects and slight to moderate corneal infection occurred in the eyes of 16 and 2 patients, respectively, all were treated successfully with no eye perforation.
Long-term visual improvement was achievable in cases of complete LSCD. Cultivated oral mucosal epithelial sheet transplantation offered substantial visual improvement even for patients with end-stage severe ocular surface disorders accompanying severe tear deficiency. Patients with corneal blindness such as SJS benefited from critical improvement of visual acuity.
FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in anymaterials discussed in this article.
报告培养的口腔黏膜上皮片移植（COMET）的有效性、疾病特异性结局和安全性，主要目的是改善视力。
非对照、回顾性、干预性病例系列研究。
本研究纳入了 40 例完全性角膜缘干细胞缺乏症（LSCD）患者的 46 只眼，这些患者接受 COMET 治疗以改善视力。这些 LSCD 疾病分为以下 4 类：史蒂文斯-约翰逊综合征（SJS；21 只眼）、眼瘢痕性类天疱疮（OCP；10 只眼）、热或化学损伤（7 只眼）或其他疾病（8 只眼）。
在手术前、术后第 4、12 和 24 周以及最后一次随访时，检查最佳矫正视力（BCVA）和眼表面分级评分。收集与 COMET 相关的不良事件和术后管理数据。分别评估每个疾病类别的结果。
主要结局是术后 24 周时中位数对数最小角分辨率（logMAR）BCVA 的变化。次要结局是眼表面分级评分。
基线时中位数 logMAR BCVA 为 2.40（范围，1.10 至 3.00）。在 SJS 中，手术后 24 周内 logMAR BCVA 显著改善。相比之下，OCP 的 BCVA 仅在术后第 4 周显著改善。在 7 例热或化学损伤病例中，计划行穿透性角膜移植或深板层角膜移植后 logMAR BCVA 改善。所有类别眼表面异常的分级评分均改善。在 31 例基线视力丧失（logMAR BCVA>2）的患者中，15 例（48%）通过 COMET 治疗得到改善（logMAR BCVA≤2）。长期随访（中位数 28.7 个月）保持了视力改善。多变量逐步逻辑回归分析显示，角膜新生血管和睑球粘连与术后 24 周时 logMAR BCVA 的改善显著相关（P=0.0023 和 P=0.0173）。尽管 16 只眼和 2 只眼分别出现术后持续性上皮缺损和轻微至中度角膜感染，但所有眼均成功治愈，无一例眼穿孔。
在完全性 LSCD 病例中可实现长期视力改善。即使对于伴有严重泪液缺乏的终末期严重眼表面疾病的患者，培养的口腔黏膜上皮片移植也能显著提高视力。患有 SJS 等角膜盲症的患者受益于视力的显著改善。
作者没有与本文讨论的任何材料有专有的或商业的利益。
