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

NCT ID: NCT00347347

Last Updated: 2010-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Myopia; Refractive Error

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. As part of the ophthalmic evaluation, will undergo non-cycloplegic and cycloplegic refraction.

2. Informed consent has been obtained from a parent or guardian.

3. Aged between 4 years and 13 years old.

4. Able to cooperate with examination(s) as stated.

Exclusion Criteria

1. Known allergy or adverse reaction to cyclopentolate.

2. Unable to cooperate with examination(s) stated.

3. Parent or guardian objection.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Singapore Eye Research Institute

OTHER

Sponsor Role: collaborator

Singapore National Eye Centre

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Yvonne Ling, FRCS(G)

Role: PRINCIPAL_INVESTIGATOR

Singapore National Eye Centre

Locations

Singapore National Eye Centre

Singapore, , Singapore

Countries

Singapore

Other Identifiers

R456/05/2006

Identifier Type: -

Identifier Source: org_study_id