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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
Sponsor:
Collaborator:
Singapore Eye Research Institute
Information provided by:
Singapore National Eye Centre

Tracking Information
First Submitted Date June 30, 2006
First Posted Date July 4, 2006
Last Update Posted Date May 12, 2010
Study Start Date February 2006
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2010)
  • 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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Study of Cycloplegic Refraction and Subjective Refraction With Fogging in School Age Children
Official Title Not Provided
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children aged 4-13 years old.
Condition
  • Myopia
  • Refractive Error
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: June 30, 2006)
150
Original Enrollment Same as current
Actual Study Completion Date December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 13 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Singapore
Removed Location Countries  
 
Administrative Information
NCT Number NCT00347347
Other Study ID Numbers R456/05/2006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Singapore National Eye Centre
Collaborators Singapore Eye Research Institute
Investigators
Principal Investigator: Yvonne Ling, FRCS(G) Singapore National Eye Centre
PRS Account Singapore National Eye Centre
Verification Date May 2010