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

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00347347
• Other study ID #: R456/05/2006
• Status: Completed
• Phase: N/A
• First received: June 30, 2006
• Last updated: May 11, 2010
• Start date: February 2006
• Est. completion date: December 2008

Study information

• Verified date: May 2010
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 13 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myopia
• Refractive Error
• Refractive Errors

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore National Eye Centre	Singapore Eye Research Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean spherical error (MSE) of less than or equal to 0.50D between the non-cycloplegic and cycloplegic refractive results .
Primary	MSE calculated by subtracting the non-cycloplegic spherical error from the cycloplegic spherical error.