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临床试验/NCT03758859
NCT03758859Unknown不适用

CLARITY Imaging Study: The Effect Of Cross-linked Sodium Hyaluronate On The Quality Of Optical Coherence Tomography Imaging

Imperial College London2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年4月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
2
主要终点
Clarity of retinal images obtained by Optical Coherence Tomography.

研究概览

简要总结

OCT image quality is necessary to provide accurate diagnostic information to ophthalmologists. The increasing resolution of imaging techniques will require ever more high standards of optical transmission through the cornea and tear film. Given that lubricant drops can improve optical transmission through the cornea, this study will attempt to quantify this. The primary objective is to assess the effect of cross-linked sodium hyaluronate on OCT image quality compared to the effect of blinking alone.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

Randomisation is between eyes i.e. eye exposed to blinking alone vs eye exposed to lubricant drops

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 subjectively deemed to have poor image quality by the photographer

排除标准

  • Patients with a known adverse reaction to any of the constituents of the XLHA
  • Patients wearing contact lenses
  • Patients who have used eyedrops in the past 2 hours

研究组 & 干预措施

sodium hyaluronate eye drops

Experimental

the randomly allocated eye will receive sodium hyaluronate drops, followed by a repeat OCT scan; images are then evaluated for clarity by the masked assessor.

干预措施: sodium hyaluronate eyedrops (Other)

结局指标

主要结局

Clarity of retinal images obtained by Optical Coherence Tomography.

时间窗: immediately after the administration of drops.

Signal strength of OCT scan

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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