NCT00347347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 12, 2010

Status Verified

May 1, 2010

Enrollment Period

2.8 years

First QC Date

June 30, 2006

Last Update Submit

May 11, 2010

Conditions

MyopiaRefractive Error

Outcome Measures

Primary Outcomes (2)

  • 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.

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 4-13 years old.

You may qualify if:

  • As part of the ophthalmic evaluation, will undergo non-cycloplegic and cycloplegic refraction.
  • Informed consent has been obtained from a parent or guardian.
  • Aged between 4 years and 13 years old.
  • Able to cooperate with examination(s) as stated.

You may not qualify if:

  • Known allergy or adverse reaction to cyclopentolate.
  • Unable to cooperate with examination(s) stated.
  • Parent or guardian objection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

MyopiaRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Yvonne Ling, FRCS(G)

    Singapore National Eye Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 12, 2010

Record last verified: 2010-05

Locations

SG(1)