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

Sponsor
Singapore National Eye Centre (Other)
Overall Status
Completed
CT.gov ID
NCT00347347
Collaborator
Singapore Eye Research Institute (Other)
150
Enrollment
1
Location
34
Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Feb 1, 2006
    Actual Primary Completion Date :
    Dec 1, 2008
    Actual Study Completion Date :
    Dec 1, 2008

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 13 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Singapore National Eye Centre Singapore Singapore 168751

    Sponsors and Collaborators

    • Singapore National Eye Centre
    • Singapore Eye Research Institute

    Investigators

    • Principal Investigator: Yvonne Ling, FRCS(G), Singapore National Eye Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00347347
    Other Study ID Numbers:
    • R456/05/2006
    First Posted:
    Jul 4, 2006
    Last Update Posted:
    May 12, 2010
    Last Verified:
    May 1, 2010
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of May 12, 2010