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Study of Myopia Prevention in Children With Low Concentration of Atropine

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Min-Sheng General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myopia Drug: atropine Drug: tropicamide Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Study of Prevention Myopia in Children With Low Concentration of Atropine
Study Start Date : April 2007
Estimated Study Completion Date : March 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
use 0.25% atropine once a week
 Drug: atropine
0.25% atropine
Active Comparator: 2
use 0.5% tropicamide everyday
 Drug: tropicamide
0.5% tropicamide


Outcome Measures
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Primary Outcome Measures :
  1. cycloplegic refraction, visual acuity [ Time Frame: one year ]

Secondary Outcome Measures :
  1. axial length [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00541177


Contacts
Contact: Leon Chih-Kai Liang, MD MMS 03-3179599 ext 8333 eye.care@msa.hinet.net

Locations
Taiwan
Min-Sheng General Hospital Recruiting
Tao-Yuan, Taiwan
Sponsors and Collaborators
Min-Sheng General Hospital
Investigators
Principal Investigator: Leon Chih-Kai Liang, MD MMS Min-Sheng General Hospital; National Yang-Ming university, Taiwan
More Information
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ClinicalTrials.gov Identifier: NCT00541177     History of Changes
Other Study ID Numbers: IRB960209-3
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: October 10, 2007
Last Verified: October 2007

Keywords provided by Min-Sheng General Hospital:
prevention myopia

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases
Atropine
Tropicamide
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action