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Study of Myopia Prevention in Children With Low Concentration of Atropine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00541177
Recruitment Status : Unknown
Verified October 2007 by Min-Sheng General Hospital.
Recruitment status was:  Recruiting
First Posted : October 10, 2007
Last Update Posted : October 10, 2007
Information provided by:
Min-Sheng General Hospital

Tracking Information
First Submitted Date  ICMJE October 6, 2007
First Posted Date  ICMJE October 10, 2007
Last Update Posted Date October 10, 2007
Study Start Date  ICMJE April 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
cycloplegic refraction, visual acuity [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
axial length [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of Myopia Prevention in Children With Low Concentration of Atropine
Official Title  ICMJE Pilot Study of Prevention Myopia in Children With Low Concentration of Atropine
Brief Summary The purpose of this study is to test the hypothesis that myopia can be prevented by using a low concentration of atropine eyedrops once a week.
Detailed Description

The prevalence rate of myopia is rising rapidly in several Asian countries. A prevalence survey conducted in 1995 of 11178 school children in Taiwan were 12 percent for six year old and 84 percent for teenagers 16 o 18 years. Among them, twenty percent were high myopes. While in the United States and Europe the prevalence rate in older adults is 20% to 50%. The rate of progression of myopia is highest in young children, and the average age of stabilization of myopia is approximately 16 years.The onset of myopia may occur at a relatively young age, leading to higher risks of high myopia (myopia at least 6.0 diopters ) in adulthood. High myopia is associated with potentially blinding complications. Therefore, prevention of myopia progression is important in Taiwan, especially in young children.

There is some evidence that atropine eyedrops retard myopia progression in three randomized clinical trials. It is believed that atropine act on muscarinic receptor located in the sclera and through some unknown mechanism retard the elongation rate of axial length. However, the possible long-term side effects such as cataract formation and retinal toxicity, are largely unknown. Photophobia in daily life, accommodation difficulty both decrease the acceptance of atropine usage and compliance.

There are some evidence that the rate of axial elongation of eyeball are different between pre-myopic stage and myopic stage. Therefore, if we can use low concentration of atropine eyedrops before myopia development. Maybe we can prevent abnormal axial length elongation with lower dosage of atropine eyedrops compared with daily use of atropine eyedrops in true myopia stage.

Clinical study was conducted by randomized control trial. 60 school-aged children were recruited ( Age 7 to 12 years ). All with pre-myopia ( spherical equivalent between +0.50 and -0.75 ) after cycloplegic refraction. Visual acuity of naked eyes are above 0.6. None of them had tropia, amblyopia, eyelid disease, ocular problems. The astigmatism was less than -1.0D and anisometropia was less than 1.0D. The children were randomly assigned into two groups by using randomized consent design. The first group use 0.25% atropine once a week. The second group keep traditional treatment using 0.5% tropicamide eyedrop every day. All children had complete ophthalmologic examination before enrollment. Follow-up examinations were performed every 3 months for 12 months duration. These examinations included visual acuity of naked eye. Intraocular pressure, refractive status. The cycloplegic refraction and axial length were measured every 6 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Myopia
Intervention  ICMJE
  • Drug: atropine
    0.25% atropine
  • Drug: tropicamide
    0.5% tropicamide
Study Arms  ICMJE
  • Experimental: 1
    use 0.25% atropine once a week
    Intervention: Drug: atropine
  • Active Comparator: 2
    use 0.5% tropicamide everyday
    Intervention: Drug: tropicamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 9, 2007)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 7 to 12 years old
  • Has pre-myopia (spherical equivalent between +0.50 and -0.75) after cycloplegic refraction.
  • Visual acuity of naked eyes are above 0.6.
  • Astigmatism is less than -1.0D and anisometropia less than 1.0D.

Exclusion Criteria:

  • Has tropia, amblyopia, eyelid disease, or ocular problems.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00541177
Other Study ID Numbers  ICMJE IRB960209-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Min-Sheng General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leon Chih-Kai Liang, MD MMS Min-Sheng General Hospital; National Yang-Ming university, Taiwan
PRS Account Min-Sheng General Hospital
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP