Study of Myopia Prevention in Children With Low Concentration of Atropine

NCT ID: NCT00541177

Last Updated: 2007-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-03-31

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.

Conditions

Myopia

Keywords

prevention myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

use 0.25% atropine once a week

Group Type: EXPERIMENTAL

atropine

Intervention Type: DRUG

0.25% atropine

2

use 0.5% tropicamide everyday

Group Type: ACTIVE_COMPARATOR

tropicamide

Intervention Type: DRUG

0.5% tropicamide

Interventions

atropine

0.25% atropine

Intervention Type: DRUG

tropicamide

0.5% tropicamide

Intervention Type: DRUG

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Min-Sheng General Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Leon Chih-Kai Liang, MD MMS

Role: PRINCIPAL_INVESTIGATOR

Min-Sheng General Hospital; National Yang-Ming university, Taiwan

Locations

Min-Sheng General Hospital

Taoyuan District, Tao-Yuan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Leon Chih-Kai Liang, MD MMS

Role: CONTACT

Phone: 03-3179599

Email: eye.care@msa.hinet.net

Other Identifiers

IRB960209-3

Identifier Type: -

Identifier Source: org_study_id