Study of Myopia Prevention in Children With Low Concentration of Atropine
Primary Purpose
Myopia
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
atropine
tropicamide
Sponsored by
About this trial
This is an interventional prevention trial for Myopia focused on measuring prevention myopia
Eligibility Criteria
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.
Sites / Locations
- Min-Sheng General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
use 0.25% atropine once a week
use 0.5% tropicamide everyday
Outcomes
Primary Outcome Measures
cycloplegic refraction, visual acuity
Secondary Outcome Measures
axial length
Full Information
NCT ID
NCT00541177
First Posted
October 6, 2007
Last Updated
October 9, 2007
Sponsor
Min-Sheng General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00541177
Brief Title
Study of Myopia Prevention in Children With Low Concentration of Atropine
Official Title
Pilot Study of Prevention Myopia in Children With Low Concentration of Atropine
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Min-Sheng General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
prevention myopia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
use 0.25% atropine once a week
Arm Title
2
Arm Type
Active Comparator
Arm Description
use 0.5% tropicamide everyday
Intervention Type
Drug
Intervention Name(s)
atropine
Intervention Description
0.25% atropine
Intervention Type
Drug
Intervention Name(s)
tropicamide
Intervention Description
0.5% tropicamide
Primary Outcome Measure Information:
Title
cycloplegic refraction, visual acuity
Time Frame
one year
Secondary Outcome Measure Information:
Title
axial length
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leon Chih-Kai Liang, MD MMS
Phone
03-3179599
Ext
8333
Email
eye.care@msa.hinet.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Chih-Kai Liang, MD MMS
Organizational Affiliation
Min-Sheng General Hospital; National Yang-Ming university, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Min-Sheng General Hospital
City
Tao-Yuan
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Study of Myopia Prevention in Children With Low Concentration of Atropine
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