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临床试验/NCT03002688
NCT03002688已完成不适用

OSUWMC EEI Sequential Cataract Patient Experience Project

Ohio State University1 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
286
试验地点
1
主要终点
Pain

研究概览

简要总结

The purpose is to gauge the patients' level of comfort and anxiety for sequential cataract surgeries to assess if the second experience of cataract surgery differs from the initial experience.

详细描述

Each patient is scheduled to undergo two sequential cataract extractions under topical anesthesia with local anesthetic eye drops and minimal sedation- one on each eye. The surgeon, basic surgical procedure, anesthetic technique, and approximate length of procedure are reasonably similar and the patients act as their own control. Subjects in the study will answer very brief questions regarding anxiety and comfort about their surgery before and after each procedure, and on the day after their second surgery.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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 undergoing sequential cataract surgeries within a 6 week time period performed by the ophthalmologist, Amit Tandon, MD.
  • Aged 18 years and older.

排除标准

  • Cognitive impairment causing inability to participate in survey
  • Language barrier causing an inability to participate in survey
  • Healthcare POA or guardian leading to an inability to consent to survey
  • Physician autonomy; patients that are inappropriate for the study as deemed by investigator

结局指标

主要结局

Pain

时间窗: First and second cataract extraction surgery occuring within 6 weeks

Pain will be evaluated using verbal survey after each cataract surgery, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in pain between surgeries on the day after the second cataract surgery.

Anxiety

时间窗: First and second cataract extraction surgery occuring within 6 weeks

Anxiety will be evaluated using verbal survey before each cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in anxiety between surgeries on the day after the second cataract surgery.

Awareness

时间窗: First and second cataract extraction surgery occuring within 6 weeks

Awareness will be evaluated using verbal survey after each cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in awareness between surgeries on the day after the second cataract surgery.

Comfort Level

时间窗: First and second cataract extraction surgery occuring within 6 weeks

Comfort level will be evaluated using verbal survey after cataract surgeries, scheduled to occur within 6 weeks time; subject will be asked if there was any difference in comfort level between surgeries on the day after the second cataract surgery.

次要结局

未报告次要终点

研究者

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

Deborah Lowery

Assistant Professor Clinical Anesthesiology

Ohio State University

研究点 (1)

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