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临床试验/NCT00347347
NCT00347347已完成不适用

Comparative Study of Cycloplegic Refraction and Subjective Refraction With Fogging in School Age Children

Singapore National Eye Centre1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2006年2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
150
试验地点
1
主要终点
Mean spherical error (MSE) of less than or equal to 0.50D between the non-cycloplegic and cycloplegic refractive results .

研究概览

简要总结

A thorough ophthalmic examination of a child must include a refraction and this is often done with cycloplegia. In our study, we aim to determine at which age group a non-cycloplegic refraction technique closely correlates with a cycloplegic refraction and hence, would obviate the need for cycloplegic refraction in our routine clinical practice.

详细描述

The accommodative response in young phakic patients has been known to result in over-estimation of myopia and subsequently inappropriate prescriptions. Therefore, the rationale for cycloplegia is to inhibit the accommodative response in order to obtain a true measurement of the refractive error.

Different cycloplegic agents have been in common use for the last five decades. Cyclopentolate is widely used and is commercially available in concentrations of 0.5% and 1%. Tropicamide is another widely used cycloplegic agent and is available in 0.5% and 1% concentrations.

The advantages of a non-cycloplegic technique would be firstly, the avoidance of any possible harmful effects from the cycloplegic agents used. Secondly, it would vastly reduce waiting times for parents and children and allow for a much more efficient clinical service. Finally, there may be a significant cost-saving feature involved if these cycloplegic agents are no longer required.

This will be a prospective clinical audit/survey involving children between the ages of 4 years and 13 years who attend the paediatric ophthalmology clinics in KK Women's and Children's Hospital as well as the Singapore National Eye Centre.

All eligible children will have had a cycloplegic refraction and a non-cycloplegic refraction with fogging. A survey of children between the ages of 4 and 13 years who have had refraction with both these techniques will be undertaken and the difference in spherical error between the 2 techniques will be recorded for each child. We aim to accumulate 15 children from each age group.

研究设计

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

入排标准

年龄范围
4 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • As part of the ophthalmic evaluation, will undergo non-cycloplegic and cycloplegic refraction.
  • Informed consent has been obtained from a parent or guardian.
  • Aged between 4 years and 13 years old.
  • Able to cooperate with examination(s) as stated.

排除标准

  • Known allergy or adverse reaction to cyclopentolate.
  • Unable to cooperate with examination(s) stated.
  • Parent or guardian objection.

结局指标

主要结局

Mean spherical error (MSE) of less than or equal to 0.50D between the non-cycloplegic and cycloplegic refractive results .

MSE calculated by subtracting the non-cycloplegic spherical error from the cycloplegic spherical error.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (1)

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