Save Sight Institute, Discipline of Ophthalmology, Sydney Medical School, The University of Sydney , Sydney, New South Wales, Australia.
Bio/polymers Research Group, Department of Chemistry, The University of Alabama in Huntsville , Huntsville, USA.
Curr Eye Res. 2020 Sep;45(9):1025-1030. doi: 10.1080/02713683.2020.1764052. Epub 2020 May 27.
To review the use of clinical corneal sealants for the closure of full thickness corneal wounds.
A systematic review was conducted across CENTRAL, Medline, PubMed, Embase, Scopus, mRCT and ICTRP for the keywords of 'cornea', 'full-thickness wound', 'sealant' and their synonyms. Only evidence level 2 of higher as graded by Oxford Centre of Evidence-based Medicine were included for this review.
Seven studies were included; three randomized controlled trials investigated ReSure® sealant, 2 OcuSeal®, 1 human fibrin glue vs cyanoacrylate and 1 human fibrin glue as an adjunct to sutures vs sutures alone in penetrating keratoplasty. ReSure® was superior to suture for sealing leaking corneal incisions after cataract surgery despite provocation. ReSure® sealant has not been tested on complex full thickness corneal wounds, perforated ulcers or penetrating keratoplasty. OcuSeal® was also able to seal full thickness cornea wound post-cataract surgery to prevent ingress of Trypan blue dye. Human fibrin glue and cyanoacrylate were similarly effective in treating corneal perforations <3 mm of mixed etiologies.
There are limited high-level evidence for corneal sealants. The currently available sealants with human data are ReSure®, OcuSeal®, human fibrin glue and cyanoacrylates. While ReSure® and OcuSeal® are effective post-cataract surgery, there are no data for perforations from other etiologies. Post-approval data from ReSure® registry report good tolerability and no apparent safety concerns.
回顾临床角膜密封剂在全层角膜伤口闭合中的应用。
通过 CENTRAL、Medline、PubMed、Embase、Scopus、mRCT 和 ICTRP 系统检索“角膜”、“全层伤口”、“密封剂”及其同义词的关键词。本综述仅纳入牛津循证医学中心分级为 2 级及以上的证据。
纳入了 7 项研究;3 项随机对照试验研究了 ReSure®密封剂、2 项 OcuSeal®、1 项人纤维蛋白胶与氰基丙烯酸酯以及 1 项人纤维蛋白胶作为缝线辅助与单独缝线在穿透性角膜移植术中的应用。尽管有刺激作用,ReSure®在白内障手术后密封渗漏性角膜切口方面优于缝线。ReSure®密封剂尚未在复杂全层角膜伤口、穿孔性溃疡或穿透性角膜移植术中进行测试。OcuSeal®也能够在白内障手术后密封全层角膜伤口,防止锥虫蓝染料进入。人纤维蛋白胶和氰基丙烯酸酯在治疗混合病因<3mm 的角膜穿孔方面同样有效。
角膜密封剂的高质量证据有限。目前有人类数据的可用密封剂包括 ReSure®、OcuSeal®、人纤维蛋白胶和氰基丙烯酸酯。虽然 ReSure®和 OcuSeal®在白内障手术后有效,但对于其他病因引起的穿孔没有数据。ReSure®注册研究的上市后数据报告了良好的耐受性,没有明显的安全问题。