Comparative Study of Cycloplegic Refraction and Subjective Refraction With Fogging in School Age Children
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|ClinicalTrials.gov Identifier: NCT00347347|
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : May 12, 2010
|Condition or disease|
|Myopia Refractive Error|
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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347347
|Singapore National Eye Centre|
|Singapore, Singapore, 168751|
|Principal Investigator:||Yvonne Ling, FRCS(G)||Singapore National Eye Centre|