跳至主要内容
临床试验/NCT03760770
NCT03760770Unknown不适用

Riboflavin at 4ºC for the Management of Pain After Crosslinking for Keratoconus Patients

Instituto de Oftalmología Fundación Conde de Valenciana2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Change pain perception in patients undergoing crosslinking with riboflavin at 4ºC

研究概览

简要总结

Background: The objective of corneal collagen crosslinking (CXL) is to increase the binding of intrafibrillary and interfibrillary covalent bonds to improve the mechanical stability of the cornea and thus to stop the progression of corneal ectasias. Although the vast majority of studies have described pain after photorefractive keratectomy (PRK), the pathophysiological principle of pain is similar in CXL. From the anatomical point of view, the corneal epithelium is the most densely innervated and sensitive surface of the body, being 300-600 times greater than in the skin. The pain after CXL comes from several routes, the process begins with the epithelial rupture that generates exposure of the nerve endings, induces apoptosis and necrosis of the epithelial cells. Subsequently an inflammatory cascade is initiated in which the different cytokines stimulate the nerve terminals. Inflammatory mediators also activate the ion channels in the nerve membrane, and this process continues until the epithelium heals. Additionally, exposure to UVA rays can also cause nerve damage. The effect of local cold for pain management has already been reported in PRK. By cooling the cornea, the release of chemical mediators and inflammation can be reduced. In the CXL radiation is transformed into several forms of energy: fluorescent radiation, chemical energy and, to a small extent, heat. The CXL process is energetically comparable to photosynthesis, in which the radiation energy is transformed into chemical energy (glucose) with the help of pigments (chlorophyll). The thermal effect is negligible in the photochemical method of CXL. Justification: No method for the control of pain after crosslinking is considered ideal or universally accepted, the importance of this study lies in looking for an additional tool to reduce the most common postoperative complaint in a highly performed procedure worldwide. Hypothesis: The application of riboflavin at 4oC reduces the pain assessment after the CXL. Purpose: to evaluate the effect of the application of riboflavin at 4oC in the assessment of postoperative pain in patients undergoing CXL. Materials and methods: Prospective and interventional clinical study in patients older than 18 years with a diagnosis of keratoconus who underwent CXL, in the cornea and refractive surgery service of the Ophthalmology institute Fundación Conde de Valenciana.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients of any gender
  • older than 18 years
  • diagnosis of keratoconus who require management with crosslinking in both eyes for evidence of progression.

排除标准

  • crosslinking without removal of epithelium or unilateral crosslinking.
  • patients with other ocular conditions different from keratoconus.
  • cognitive disability that limits the compression of the pain test as Down syndrome, etc.

研究组 & 干预措施

Riboflavin at 4ºC

Experimental

patients treated with Riboflavin at 4ºC in crosslinking (cases).

干预措施: corneal collagen crosslinking (Procedure)

Riboflavin at room temperature

Experimental

patients treated with Riboflavin at room temperature in crosslinking (controls)

干预措施: corneal collagen crosslinking (Procedure)

结局指标

主要结局

Change pain perception in patients undergoing crosslinking with riboflavin at 4ºC

时间窗: 2 postoperative hours and from day 1 to 5 postoperative.

A previously validated numerical pain scale questionnaire was applied. Patients are asked to indicate their pain intensity on a scale of 0 to 10, explaining that 0 does not represent pain at all and 10 is a severe and disabling pain.

次要结局

未报告次要终点

研究者

发起方
Instituto de Oftalmología Fundación Conde de Valenciana
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验