Department of Ophthalmology, University Hospital Split, Split, Croatia.
Laboratory for Pain Research Department of Anatomy, Histology and Embryology, University of Split School of Medicine, Split, Croatia.
BMJ Open. 2018 Jun 27;8(6):e020714. doi: 10.1136/bmjopen-2017-020714.
Pterygium is a non-cancerous growth of the conjunctival tissue over the cornea that may lead to visual impairment in advanced stages, restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence of pterygium is a frequent problem. It has been previously shown that fibrin glue may result in less recurrence and may take less time than sutures for fixing the conjunctival graft in place during pterygium surgery. However, fibrin glue is a biological material and it carries the risk of transmitting infectious agents from pooled and single-donor blood donors and anaphylaxis in susceptible individuals. Cauterisation is another surgical option, and it would be advantageous to know whether cauterisation may be superior surgical option compared with fibrin glue. This protocol describes the rationale and design of the randomised controlled trial (RCT) in which we will compare cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery.
This will be a parallel group RCT comparing cauterisation versus fibrin glue for conjunctival autografting in primary pterygium surgery. Computer-generated randomisation will be used, and allocation concealment will be conducted using sequentially numbered opaque sealed envelopes. Surgeons will not be blinded to the procedures, but participants, other investigators and outcome assessors will be blinded. Adult participants with primary pterygium operated in a tertiary hospital in Split, Croatia, will be included. Primary outcome will be recurrence of pterygium, defined as any regrowth of tissue from the area of excision across the limbus onto the cornea after 180 days.
The trial was approved by the ethics review board of the University Hospital Split (500-03/17-01/68). Results will be disseminated at conferences and through peer-reviewed publications.
NCT03321201; Pre-results.
翼状胬肉是一种结膜组织在角膜上的非癌性生长，可能导致晚期视力受损、眼球运动受限、慢性炎症和美容问题。手术切除是首选治疗方法，但翼状胬肉的复发是一个常见问题。以前的研究表明，纤维蛋白胶可能会减少复发，并且在翼状胬肉手术中固定结膜移植物时，比缝线需要的时间更少。然而，纤维蛋白胶是一种生物材料，它有从汇集的和单一供体血液供体传播传染性病原体的风险，并可能在易感个体中引起过敏反应。烧灼也是另一种手术选择，如果知道烧灼是否比纤维蛋白胶更优的手术选择，这将是有利的。本方案描述了一项随机对照试验（RCT）的原理和设计，该试验将比较原发性翼状胬肉手术中烧灼与纤维蛋白胶用于结膜自体移植的效果。
这将是一项比较原发性翼状胬肉手术中烧灼与纤维蛋白胶用于结膜自体移植的平行组 RCT。将使用计算机生成的随机化，并且将使用连续编号的不透明密封信封进行分配隐藏。外科医生不会对手术过程进行盲法，但参与者、其他研究人员和结果评估者将进行盲法。克罗地亚斯普利特的一家三级医院接受手术的原发性翼状胬肉成年患者将被纳入。主要结局是翼状胬肉的复发，定义为切除区域的任何组织在 180 天后越过角膜边缘重新生长到角膜上。
该试验已获得斯普利特大学医院伦理审查委员会的批准（500-03/17-01/68）。结果将在会议上和通过同行评审出版物传播。
NCT03321201；预结果。
