Study of Myopia Prevention in Children With Low Concentration of Atropine

Myopia Clinical Trial

Official title:

Pilot Study of Prevention Myopia in Children With Low Concentration of Atropine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00541177
• Other study ID #: IRB960209-3
• Status: Recruiting
• Phase: Phase 4
• First received: October 6, 2007
• Last updated: October 9, 2007
• Start date: April 2007
• Est. completion date: March 2008

Study information

• Verified date: October 2007
• Source: Min-Sheng General Hospital
• Contact: Leon Chih-Kai Liang, MD MMS
• Phone: 03-3179599
• Email: eye.care[@]msa.hinet.net
• Is FDA regulated: No
• Health authority: Taiwan: National Bureau of Controlled Drugs
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• atropine
0.25% atropine
• tropicamide
0.5% tropicamide

Locations

Country	Name	City	State
Taiwan	Min-Sheng General Hospital	Tao-Yuan

Sponsors (1)

Lead Sponsor	Collaborator
Min-Sheng General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cycloplegic refraction, visual acuity		one year
Secondary	axial length		one year