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
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.
- 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