MyopiaNCT00400140
Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children
A study testing Hyperopic lens in people with Myopia, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
The objective of this pilot study is to establish whether brief periods of high levels of acutely imposed myopic defocus can be used to slow the progression of myopia in children, as measured by changes in spherical equivalent refraction and axial length. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Hyperopic lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2006to Oct 2008
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 12 years
- Refractive error of spherical equivalent -1.00 D to -6.00D in each eye as measured by cycloplegic autorefraction
- Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power
- Astigmatism of less than or equal to -1.50 D as measured by non-cycloplegic or cycloplegic autorefraction
- Distance vision correctable to logMAR 0.1 or better in both eyes
- Normal intraocular pressure of not greater than 21 mmHg
Show all 9Show fewer
- Normal ocular health other than myopia
- In good general health
- Willing and able to comply with scheduled visits and other study procedures
Who cannot join
- Baseline Anisometropia of > 1.5D
- Ocular or systemic diseases which may affect vision or refractive error
- Defective binocular function or stereopsis
- Amblyopia or manifest strabismus including intermittent tropia
- Previous or current use of atropine or pirenzepine
- Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study
- Allergy to cyclopentolate, proparacaine and benzalkonium chloride
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this pilot study is to establish whether brief periods of high levels of acutely imposed myopic defocus can be used to slow the progression of myopia in children, as measured by changes in spherical equivalent refraction and axial length.
Read the detailed description
Recent results on animal models of myopia suggest that the eye has the ability to detect the overall sign of defocus of images falling on the retina, with myopic defocus imposed by the fitting of plus-lenses halting or slowing axial elongation of the eye. In the animal models, these STOP growth signals have been shown to be particularly strong - with brief periods of high myopic defocus able to outweigh the effects of prolonged periods of imposed hyperopic defocus in promoting eye growth. These results therefore suggest a novel strategy for preventing the progression of myopia in children - the imposition of high levels of myopia for brief periods of time. This approach is conceptually distinct from under-correction, which imposes chronic mild myopic defocus.
- Conditions
- Myopia
- Being tested
- Hyperopic lens
- Keywords
- Myopia, defocus
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperopic lensDevice
+3 D glasses
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Hyperopic lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myopia progression as measured by spherical equivalent, and axial length
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionOct 2008
- Study completionOct 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- Singapore Eye Research Institute
- Investigators
- Audrey Chia, FRANZCO, Principal investigator, Singapore National Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400140
- Sponsor's protocol ID
- R473/22/2006
- Status last verified
- May 2010
- First submitted
- 15 Nov 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
- Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children
- ClinicalTrials.gov ID
- NCT00400140
- Acronym / sponsor ID
- R473/22/2006
- Conditions
- Myopia
- Keywords
- Myopia, defocus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- Singapore Eye Research Institute
- Study start
- Nov 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 16 Nov 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.
The objective of this pilot study is to establish whether brief periods of high levels of acutely imposed myopic defocus can be used to slow the progression of myopia in children, as measured by changes in spherical equivalent refraction and axial length.
Detailed description
Recent results on animal models of myopia suggest that the eye has the ability to detect the overall sign of defocus of images falling on the retina, with myopic defocus imposed by the fitting of plus-lenses halting or slowing axial elongation of the eye. In the animal models, these STOP growth signals have been shown to be particularly strong - with brief periods of high myopic defocus able to outweigh the effects of prolonged periods of imposed hyperopic defocus in promoting eye growth. These results therefore suggest a novel strategy for preventing the progression of myopia in children - the imposition of high levels of myopia for brief periods of time. This approach is conceptually distinct from under-correction, which imposes chronic mild myopic defocus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Hyperopic lens |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children aged 6 to 12 years
- Refractive error of spherical equivalent -1.00 D to -6.00D in each eye as measured by cycloplegic autorefraction
- Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power
- Astigmatism of less than or equal to -1.50 D as measured by non-cycloplegic or cycloplegic autorefraction
- Distance vision correctable to logMAR 0.1 or better in both eyes
Key exclusion criteria (7 listed)
- Baseline Anisometropia of > 1.5D
- Ocular or systemic diseases which may affect vision or refractive error
- Defective binocular function or stereopsis
- Amblyopia or manifest strabismus including intermittent tropia
- Previous or current use of atropine or pirenzepine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperopic lens+3 D glasses | Device | A |
Primary outcome
Myopia progression as measured by spherical equivalent, and axial length
Time frame: 12 month
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.
Audrey Chia, FRANZCO principal investigator
Singapore National Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperopic lens in people with Myopia, 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 9 inclusion and 7 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?
Myopia progression as measured by spherical equivalent, and axial length (time frame: 12 month). 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; AzTrials last refreshed its copy on 7 Nov 2026.