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临床试验/NCT04144985
NCT04144985已完成不适用

Eyelid Retraction Discomfort With Cotton Tipped Applicator, Unimanual and Speculum Intravitreal Injection Techniques: Eyelid Retraction Technique Randomized Comparison Trial (Eyelid RETRACT)

New York City Health and Hospitals Corporation2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2017年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
99
试验地点
2
主要终点
Pain Associated with Different Eyelid Retraction Technique

研究概览

简要总结

This study evaluated the discomfort associated with eyelid retraction during intravitreal injections. Participants had eyelid retraction with one of three methods: eyelid speculum, unimanual eyelid retraction method or with a cotton tipped applicator eyelid retraction technique. All participants were given a pain survey immediately after the injection to evaluate their discomfort level.

详细描述

Comfort is an important factor in compliance and satisfaction during medical care With the millions of intravitreal injections done each year, even small improvements in participants' experiences could lead to significant benefit. During the process eye injections, the method of eyelid retraction has been shown to be one of the most significant sources of discomfort.

Many ophthalmologists use an eyelid speculum to retract the eyelids, but potentially more comfortable methods exist. The purpose of our study was to test the comfort eyelid retraction with an eyelid speculum to that of the unimanual eyelid retraction method and a cotton tipped applicator eyelid retraction technique.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Adult participants receiving an intravitreal injection

排除标准

  • iodine allergy
  • prior ocular surgery other than uncomplicated cataract surgery

研究组 & 干预措施

Eyelid Speculum

Active Comparator

Eyelid retraction was performed with an eyelid speculum.

干预措施: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience. (Other)

Cotton Tipped Applicator

Experimental

Eyelid retraction was performed with the cotton tipped applicator eyelid retraction technique.

干预措施: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience. (Other)

Unimanual Eyelid Retraction

Experimental

Eyelid retraction was performed with the unimanual eyelid retraction method.

干预措施: Visual analog scale (VAS) of pain to evaluate the discomfort participants experience. (Other)

结局指标

主要结局

Pain Associated with Different Eyelid Retraction Technique

时间窗: 1 minute

Within one minute of the injection, the participant was given a standard 100mm long visual analog scale (VAS) and asked to rate their pain from 0mm (no pain) to 100mm (the worst pain) regarding the process of the intravitreal injection.

次要结局

  • Difference in Pain in Treatment Naive Participants(1 minute)
  • Associations of Hemoglobin A1c and Ocular Pain(1 minute)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph Raevis

Chief Ophthalmology Resident

New York City Health and Hospitals Corporation

研究点 (2)

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