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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Error Refractive Errors

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Singapore National Eye Centre

Singapore, 168751

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Singapore National Eye Centre

Other Gov

Collaborators

Singapore Eye Research Institute

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jul 4, 2006
Registry last updated: May 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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