MyopiaNCT00347347
Comparative Study of Cycloplegic Refraction and Subjective Refraction With Fogging in School Age Children
An observational study of Myopia and Refractive Error, run by Singapore National Eye Centre at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Refractive Error
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2006to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 4-13 years old.
Who may be able to join
- 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.
Who cannot join
- Known allergy or adverse reaction to cyclopentolate.
- Unable to cooperate with examination(s) stated.
- Parent or guardian objection.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Myopia, Refractive Error
- Medical subject headings
- Myopia, Refractive Errors
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- Singapore Eye Research Institute
- Investigators
- Yvonne Ling, FRCS(G), Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347347
- Sponsor's protocol ID
- R456/05/2006
- Status last verified
- May 2010
- First submitted
- 30 Jun 2006
- Last updated
- 12 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Cycloplegic Refraction and Subjective Refraction With Fogging in School Age Children
- ClinicalTrials.gov ID
- NCT00347347
- Acronym / sponsor ID
- R456/05/2006
- Conditions
- Myopia, Refractive Error
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- Singapore Eye Research Institute
- Study start
- Feb 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 4-13 years old.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Known allergy or adverse reaction to cyclopentolate.
- Unable to cooperate with examination(s) stated.
- Parent or guardian objection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Ling, FRCS(G) principal investigator
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Refractive Error, run by Singapore National Eye Centre at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean spherical error (MSE) of less than or equal to 0.50D between the non-cycloplegic and cycloplegic refractive results .. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010.