Refractive Error - MyopiaPhase 1NCT00348166
Does Undercorrection of Myopia Retard Myopia Progression Among Kindergarten Children?
A Phase 1 study testing cyclopentolate in people with Refractive Error - Myopia, run by KK Women's and Children's Hospital.
Trial summary
The purpose of this study is to find out if undercorrection of myopia slow down the progression of myopia in kindergarten children. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Error - Myopia
- What is being tested?
- cyclopentolate
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jun 2008
- Phase
- Phase 1
- 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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of chinese descent aged 5 - 6yrs
- Refractive error of -1.00 to -3.00Ds
- Less than 1.50 astigmatism in each eye. (No oblique axis)
- Visual acuity is 6/6 or better in both eyes.
- No binocular problems, no anisometropia >1.50D
- Will be staying in S'pore for at least 2 years.
Who cannot join
- -
About this study
Official title: Does Undercorrection of Myopia Retard Myopia Progression Among Kindergarten
The purpose of this study is to find out if undercorrection of myopia slow down the progression of myopia in kindergarten children.
- Conditions
- Refractive Error - Myopia
- Being tested
- cyclopentolate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclopentolateDrug
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 startDec 2005
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Stringent eligibility criterion caused difficulties in recruiting patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive Error - MyopiaStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe 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 1
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Investigators
- Quah Boon Long, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348166
- Sponsor's protocol ID
- RAU/085/2005
- Status last verified
- Oct 2011
- First submitted
- 3 Jul 2006
- Last updated
- 5 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Undercorrection of Myopia Retard Myopia Progression Among Kindergarten
- ClinicalTrials.gov ID
- NCT00348166
- Acronym / sponsor ID
- RAU/085/2005
- Conditions
- Refractive Error - Myopia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stringent eligibility criterion caused difficulties in recruiting patients.
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- Dec 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 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.
The purpose of this study is to find out if undercorrection of myopia slow down the progression of myopia in kindergarten children.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children of chinese descent aged 5 - 6yrs
- Refractive error of -1.00 to -3.00Ds
- Less than 1.50 astigmatism in each eye. (No oblique axis)
- Visual acuity is 6/6 or better in both eyes.
- No binocular problems, no anisometropia >1.50D
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| cyclopentolate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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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.
Quah Boon Long principal investigator
Singapore National Eye Centre
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cyclopentolate in people with Refractive Error - Myopia, run by KK Women's and Children's Hospital.
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 6 inclusion and 1 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: withdrawn, as of the sponsor's last update on 5 Oct 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 5 Oct 2011.