Table_1_Outcomes of the advanced visualization in corneal surgery evaluation trial; a non-inferiority randomized control trial to evaluate the use of intraoperative OCT during Descemet membrane endothelial keratoplasty.docx

ObjectiveTo evaluate if an intraoperative-OCT (iOCT) optimized surgical protocol without prolonged overpressure is non-inferior to a standard protocol during Descemet membrane endothelial keratoplasty (DMEK).
MethodsSixty-five pseudophakic eyes of 65 patients with Fuchs endothelial dystrophy scheduled for routine DMEK were recruited in this prospective non-inferiority international multicenter randomized control trial. Subjects were randomized to the control arm (n=33) without iOCT-use and raising the intraocular pressure above normal physiological limits for 8 minutes (i.e., overpressure) or the intervention arm (n=32) with OCT-guidance to assess graft orientation and adherence, while refraining from prolonged overpressure. The primary outcome was the incidence of postoperative surgery-related adverse events (AE). The non-inferiority margin was set at a risk difference of 10%. Secondary outcomes included iOCT-aided surgical decision making, surgical times, and endothelial cell density (ECD) corrected distance visual acuity (CDVA) at 6 months follow-up.
ResultsIn the intervention group, 12 subjects developed 13 AEs compared to 13 AEs in 10 subjects in the control group (P=0.644). The risk difference measured -0.32% (95%CI: -10.29 – 9.84). The ECD and CDVA did not differ between the two groups 3 and 6 months postoperatively (P=>0.05). Surgeons reported that iOCT aided surgical decision-making in 40% of cases. Surgery and graft unfolding time were, respectively, 13% and 27% shorter in the iOCT-group.
ConclusionsiOCT-guided DMEK surgery with refraining from prolonged over-pressuring was non-inferior compared to conventional treatment. Surgery times were reduced considerably and iOCT aided surgical decision-making in 40% of cases. Refraining from prolonged overpressure did not affect postoperative ECD or CDVA.
Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/NCT03763721 (NCT03763721).

研究目的：评估在后弹力膜内皮角膜移植术（Descemet membrane endothelial keratoplasty，DMEK）中，不采用长时间过度加压的术中光学相干断层扫描（intraoperative-OCT，iOCT）优化手术方案，是否不劣于标准手术方案。
研究方法：本项前瞻性非劣效性国际多中心随机对照试验，共招募65名患有富克斯内皮营养不良（Fuchs endothelial dystrophy）的假晶状体眼患者（共65只患眼），均计划行常规DMEK手术。受试者被随机分配至对照组（n=33）与干预组（n=32）：对照组不使用iOCT，且将眼内压升高至正常生理上限以上并持续8分钟（即过度加压）；干预组采用OCT引导评估植片定位与贴合情况，且避免长时间过度加压。本研究的主要结局指标为术后手术相关不良事件（adverse event，AE）发生率，非劣效性界值设定为风险差10%。次要结局指标包括iOCT辅助的手术决策情况、手术时长，以及术后6个月随访时的内皮细胞密度（endothelial cell density，ECD）与矫正远视力（corrected distance visual acuity，CDVA）。
研究结果：干预组中12名受试者共发生13例不良事件，对照组中10名受试者共发生13例不良事件（P=0.644），风险差为-0.32%（95%置信区间：-10.29~9.84）。术后3个月与6个月时，两组的ECD与CDVA均无显著差异（P>0.05）。外科医生报告称，40%的病例通过iOCT辅助完成手术决策。干预组的手术总时长与植片展开时长分别缩短了13%与27%。
研究结论：采用避免长时间过度加压的iOCT引导下DMEK手术，其疗效不劣于传统标准手术方案。该术式可显著缩短手术时长，且40%的病例可通过iOCT辅助完成手术决策。避免长时间过度加压不会对术后ECD水平与CDVA造成影响。
临床试验注册：https://clinicaltrials.gov/ct2/show/NCT03763721（NCT03763721）