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

This study has been completed.
Sponsor:
Collaborator:
Singapore Eye Research Institute
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT00347347
First received: June 30, 2006
Last updated: May 11, 2010
Last verified: May 2010
  Purpose

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
Myopia
Refractive Error

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 150
Study Start Date: February 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   4 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children aged 4-13 years old.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347347

Locations
Singapore
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00347347     History of Changes
Other Study ID Numbers: R456/05/2006
Study First Received: June 30, 2006
Last Updated: May 11, 2010
Health Authority: Singapore: Domain Specific Review Boards

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 22, 2014