MyopiaPLSNCT00627874
Trial of Myopia Prevention Using +3D Lenses
A study testing +3D Lenses in people with Myopia, run by Sun Yat-sen University.
Trial summary
The purpose of this study is to assess whether a short-term imposed myopic defocus is effective in preventing the development and progression of juvenile-onset myopia in Chinese children. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myopia
- What is being tested?
- +3D Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Apr 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All children in the selected class are enrolled
Who cannot join
- Hyperopia > +2.0 D
- High myopia > -6.0 D
- Astigmatism> 1.5 D
- Anisometropia > 1.5 D
- Strabismus and amblyopia
- Any ocular, systemic, or neurodevelopmental conditions that could influence refractive development
- Chronic medication use that might affect myopia progression or visual acuity
- Already receiving other treatment for progressing myopia
About this study
Official title: A Randomised, Controlled Trial of Prevention of Juvenile-Onset Myopia in Chinese Children
The purpose of this study is to assess whether a short-term imposed myopic defocus is effective in preventing the development and progression of juvenile-onset myopia in Chinese children.
Read the detailed description
- To determine if +3D lenses wearing for half an hour everyday prevents the development and progression of myopia in school children.
- To identify ocular parameters and risk factors at baseline associated with development and progression of myopia.
- Conditions
- Myopia
- Being tested
- +3D Lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
+3D LensesDevice
wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m Receives: Device: +3D Lenses |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Length of eyes
Measured: Annual
Secondary outcomes (1)
Autorefraction
Measured: Annual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startApr 2010
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
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.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Australian National University
- Investigators
- Mingguang He, PhD, MD, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627874
- Sponsor's protocol ID
- PLS2008
- Acronym
- PLS
- Status last verified
- Feb 2009
- First submitted
- 20 Feb 2008
- Last updated
- 24 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled Trial of Prevention of Juvenile-Onset Myopia in Chinese Children
- ClinicalTrials.gov ID
- NCT00627874
- Acronym / sponsor ID
- PLS / PLS2008
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Australian National University
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 4 Mar 2008 (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 purpose of this study is to assess whether a short-term imposed myopic defocus is effective in preventing the development and progression of juvenile-onset myopia in Chinese children.
Detailed description
- To determine if +3D lenses wearing for half an hour everyday prevents the development and progression of myopia in school children.
- To identify ocular parameters and risk factors at baseline associated with development and progression of myopia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: +3D Lenseswear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m |
| 2 | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All children in the selected class are enrolled
Key exclusion criteria (8 listed)
- Hyperopia > +2.0 D
- High myopia > -6.0 D
- Astigmatism> 1.5 D
- Anisometropia > 1.5 D
- Strabismus and amblyopia
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 |
|---|---|---|
| +3D Lenseswear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m | Device | 1 |
Primary outcome
Axial Length of eyes
Time frame: Annual
1 secondary outcome
Autorefraction
Time frame: Annual
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
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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.
Mingguang He, PhD, MD study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing +3D Lenses in people with Myopia, run by Sun Yat-sen University.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Axial Length of eyes (time frame: Annual). 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 24 Feb 2009.