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一种基质治疗剂对圆锥角膜患者标准胶原交联后角膜上皮愈合的疗效:一项随机临床试验

Bata AM, Witkowska KJ, Wozniak PA, et al.

期刊名称:JAMA Ophthalmology

卷期:2016年第134卷第10期

摘要

重要性:圆锥角膜患者在标准角膜胶原交联后频繁发生角膜擦伤(上皮脱落)。新开发了一种新的基质治疗剂(再生剂[ RGTA ]),可以促进角膜伤口愈合。目的:评估新型基质治疗剂对圆锥角膜患者上皮脱落CXL后角膜创伤愈合的效果。设计,设置和参与者:本双盲随机临床试验纳入了2014718日至20151021日完成最后一次随访期间40例经历上皮脱落CXL圆锥角膜患者。意向性治疗人群的分析在临床药理学系与医学物理中心合作和生物医学工程、眼科和维也纳大学的医学验光部完成。干预:患者随机接受基质治疗剂或透明质酸含滴眼液,0.1%,每隔一天手术后立即开始。使用超高分辨率的光学相干断层扫描测定角膜缺损的大小(OCT)和裂隙灯照相(SLP)和荧光素染色。主要成果和措施:角膜损伤愈合率,定义为随着时间的推移缺陷的大小。结果:经历上皮脱落CXL40例患者,(男性31人;女性9人;平均[SD]年龄,31 [ 10 ]年),基质治疗剂组伤口愈合明显快于透明质酸组(4.4 vs 6.1天;平均差1.7天;95% CI0.25-3.15天;P = 008)。与透明质酸组相比,基质治疗剂组OCT12.4 vs.23.9毫米;平均差为11.695% CI0.8-23.5 mm2P = 045)和SLP11.9vs. 23.5毫米;平均差,11.6平方毫米;95% CI1.322.9平方毫米;P = .03)测量的缺陷尺寸更小,。OCTSLP测量缺陷尺寸之间的相关性(r = 0.89P001)。无眼部或严重不良事件发生。结论及相关性:使用一种新的基质治疗剂可改进圆锥角膜患者,角膜伤口愈合。角膜伤口愈合使用超高分辨率OCT监测可能是一个有吸引力的替代品,因为SLP OCT提供了一个客观和角膜缺损的三维评价。试验注册:临床试验。政府标识符:nct02119039

Importance:Corneal abrasions are frequent after standard (epithelium-off [epi-off]) corneal collagen cross-linking (CXL) in patients with progressive keratoconus. A new matrix therapy agent (ReGeneraTing Agent [RGTA]) has been developed to promote corneal wound healing.Objective:To assess the effect of the new type of matrix therapy agent on corneal wound healing after epi-off CXL in patients with keratoconus.Design, Setting, and Participants:This double-masked randomized clinical trial enrolled 40 patients with keratoconus undergoing epi-off CXL from July 18, 2014, to October 21, 2015, when the last follow-up was completed. The analysis of the intention-to-treat population was performed at the Department of Clinical Pharmacology in cooperation with the Center for Medical Physics and Biomedical Engineering and the Department of Ophthalmology and Optometry of the Medical University of Vienna.Interventions:Patients were randomized to receive the matrix therapy agent or hyaluronic acid-containing eyedrops, 0.1%, every other day starting immediately after surgery. The size of the corneal defect was measured using ultrahigh-resolution optical coherence tomography (OCT) and slitlamp photography (SLP) with fluorescein staining.Main Outcomes and Measures:Corneal wound healing rate, defined as the size of the defect over time.Results:Among the 40 patients undergoing epi-off CXL (31 men; 9 women; mean [SD] age, 31 [10] years), wound healing was significantly faster in the matrix therapy agent group compared with the hyaluronic acid group (4.4 vs 6.1 days; mean difference, 1.7 days; 95% CI, 0.25-3.15 days; P=.008). The defect size was smaller in the matrix therapy agent group than in the hyaluronic acid group as measured with OCT (12.4 vs 23.9 mm2; mean difference, 11.6 mm2; 95% CI, 0.8-23.5 mm2; P=.045) and SLP (11.9 vs 23.5 mm2; mean difference, 11. 6 mm2; 95% CI, 1.3-22.9 mm2; P=.03). A correlation between the defect size measured with OCT and SLP was found (r=0.89; P<.001). No ocular or serious adverse events occurred.Conclusions and Relevance:Use of a new matrix therapy agent appears to improve corneal wound healing after CXL in patients with keratoconus. Monitoring of corneal wound healing using ultrahigh-resolution OCT might be an attractive alternative to SLP because OCT provides an objective and 3-dimensional evaluation of the corneal defect.Trial Registration:clinicaltrials.gov Identifier: NCT02119039.


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