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微切薄型撕囊全自动角膜内皮移植术与后弹力层角膜内皮移植术的随机临床试验。

Microthin Descemet Stripping Automated Endothelial Keratoplasty Versus Descemet Membrane Endothelial Keratoplasty: A Randomized Clinical Trial.

机构信息

Department of Ophthalmology, Cambridge University Hospitals and Cambridge Eye Research Centre, Cambridge, UK; and.

Vision and Eye Research Institute, School of Medicine, Faculty of Health, Education, Medicine and Social Care, Anglia Ruskin University, Cambridge, UK.

出版信息

Cornea. 2021 Sep 1;40(9):1117-1125. doi: 10.1097/ICO.0000000000002601.

DOI:10.1097/ICO.0000000000002601
PMID:33156076
Abstract

PURPOSE

To compare visual outcomes, complications, and vision-related quality of life (QoL) after microthin Descemet stripping automated endothelial keratoplasty (MT-DSAEK) versus Descemet membrane endothelial keratoplasty (DMEK) for the management of corneal endothelial dysfunction in Fuchs dystrophy.

METHODS

This is a prospective, double-blinded randomized controlled clinical trial. Patients with visually significant endothelial decompensation from Fuchs dystrophy were prospectively randomized to receive MT-DSAEK or DMEK surgery. The primary outcome was best spectacle-corrected visual acuity (BSCVA) at 12 months. Secondary outcomes included refraction, keratometry, endothelial cell count, complications, and vision-related QoL at 6 and 12 months postoperatively.

RESULTS

A total of 56 eyes of 56 patients were enrolled, 28 in each group. Postoperatively, LogMAR mean BSCVA in the MT-DSAEK group was 0.17 ± 0.08 and 0.11 ± 0.09 at 6 and 12 months compared with 0.09 ± 0.13 and 0.04 ± 0.13 after DMEK (P = 0.03, P = 0.002 respectively) with the DMEK cohort achieving 3.5 logarithm of the minimum angle of resolution letters better BSCVA at 1 year compared with MT-DSAEK. Complication rates were similar with 3.5% rebubbling rate in both groups, 1 primary graft failure in DMEK and a single endothelial rejection in the MT-DSAEK arm. Vision-related QoL was comparable at 6 and 12 months postoperatively, and no eyes demonstrated loss of vision from preoperative BSCVA.

CONCLUSIONS

DMEK surgery resulted in significantly better BSCVA at 1, 3, 6, and 12 months postoperatively compared with MT-DSAEK. Patient satisfaction was similar with no differences reported in vision-related QoL scores, as was the complications profile between groups. Thus, our results favor DMEK as the better choice procedure for eyes with Fuchs-related corneal decompensation without ocular comorbidities.

摘要

目的

比较微切 DESCEMET 撕囊自动化内皮角膜移植术(MT-DSAEK)与 DESCEMET 膜内皮角膜移植术(DMEK)治疗 Fuchs 营养不良性角膜内皮功能障碍的术后视力结果、并发症和视力相关生活质量(QoL)。

方法

这是一项前瞻性、双盲随机对照临床试验。前瞻性随机选择因 Fuchs 营养不良导致明显角膜内皮失代偿的患者接受 MT-DSAEK 或 DMEK 手术。主要结局是术后 12 个月的最佳矫正视力(BCVA)。次要结局包括术后 6 个月和 12 个月的屈光度、角膜曲率、内皮细胞计数、并发症和视力相关 QoL。

结果

共纳入 56 例(56 只眼)患者,每组 28 例。术后 MT-DSAEK 组的平均 LogMAR 视力分别为 0.17 ± 0.08 和 0.11 ± 0.09,而 DMEK 组分别为 0.09 ± 0.13 和 0.04 ± 0.13(P = 0.03,P = 0.002),DMEK 组术后 1 年的 BCVA 提高了 3.5 个最小分辨角对数字母。两组并发症发生率相似,Rebubbling 率均为 3.5%,DMEK 组有 1 例原发性移植物失功,MT-DSAEK 组有 1 例单纯内皮排斥反应。术后 6 个月和 12 个月的视力相关 QoL 相似,且无术前 BCVA 视力丧失的患者。

结论

与 MT-DSAEK 相比,DMEK 术后 1、3、6 和 12 个月的 BCVA 明显更好。两组患者的满意度相似,视力相关 QoL 评分无差异,并发症谱也无差异。因此,我们的研究结果支持 DMEK 作为无眼部合并症的 Fuchs 相关性角膜失代偿患者的更好选择手术。

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