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临床试验/NCT03593044
NCT03593044已完成1 期

Side Effects of Atropine (SEA) Study

Jeffrey J. Walline, OD PhD1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年7月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
31
试验地点
1
主要终点
Diameter of the Pupil Measured With a Neuroptix Pupillometer

研究概览

简要总结

This study will perform several objective and subjective measurements of the eye and vision before and after a week of using 0.01% concentration atropine drops. These measurements will help to obtain a comprehensive understanding of the side effects of this concentration of atropine and determine if the drops would be tolerated as a possible preventative treatment for nearsightedness.

详细描述

Atropine drops are commonly used to dilate the eye and prevent the ability to focus and also slow the progression of nearsightedness. Low concentration (0.01%) atropine slows the progression of myopia 60% to 83% while causing less side effects than high concentration (1.0%) atropine though still showing an effect on pupil size and pupil response.This study is a prospective cohort study in which several objective and subjective measurements will be taken before and after the use of 0.01% atropine for a week to determine the effect of this concentration on 1. vision at distance and near; 2. pupil size; 3. focusing ability, accuracy, and change; 4. symptoms, including subjective vision, headaches, light sensitivity, drop comfort; and 5. pressure in the eye. This will allow us to determine the effect these drops have on the eye and whether or not patients would be willing to use them as a possible preventative treatment for nearsightedness. The investigators expect to find that the drops will not affect vision, will increase pupil size, decrease focusing ability and accuracy (but not clinically meaningfully), cause some light sensitivity, and have no effect on eye pressure. The investigators expect that patients would be willing to use these drops to control nearsightedness even after experiencing the side effects.

研究设计

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

入排标准

年龄范围
21 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Outside of age range
  • History of accommodative (focusing) issues or therapy

研究组 & 干预措施

One Week Atropine

Experimental

0.01% concentration atropine drops

干预措施: 0.01% concentration atropine drops (Drug)

结局指标

主要结局

Diameter of the Pupil Measured With a Neuroptix Pupillometer

时间窗: Baseline (before) and one week after beginning treatment with drops

Change in pupil size between baseline visit and follow up visit (after one week on treatment) in millimeters to the nearest tenth of a millimeter

Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts

时间窗: Baseline (before) and one week after beginning treatment with drops

Investigators will measure the change in high contrast distance and near logMAR visual acuity and low contrast distance logMAR visual acuity between baseline visit and follow up visit (after one week on treatment).

次要结局

  • Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor(One week after beginning treatment with drops)
  • Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.(Baseline (before) and one week after beginning treatment with drops)
  • Change in Intraocular Pressure Using a Tonopen(Baseline (before) and one week after beginning treatment with drops)
  • Ability to Change Focus From Far to Near Measured by Stimulating and Relaxing Focus of the Eyes as Many Times as Possible in One Minute.(Baseline (before) and one week after beginning treatment with drops)

研究者

发起方
Jeffrey J. Walline, OD PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jeffrey J. Walline, OD PhD

Associate Dean For Research

Ohio State University

研究点 (1)

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