Low Concentration Atropine for Myopia Progression in School Children

Myopia Progression Clinical Trial

Official title:

Low Concentrations of Atropine for Controlling Myopia Progression in School Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02130167
• Other study ID #: CMRPG8C0601
• Status: Completed
• Phase: N/A
• First received: April 28, 2014
• Last updated: January 29, 2018
• Start date: August 2012
• Est. completion date: August 2017

Study information

• Verified date: January 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Recently the 0.01% atropine was also reported effective and with less visual side effects such as mydriasis. The aim of this study is to compare the efficacy in controlling myopia progression and visual side effects of 2 low concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

Myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.

Exclusion Criteria:

strabismus, amblyopia. cataract, glaucoma or any ocular diseases ocular surgery history systemic diseases (ex. asthma, heart disease...)

Related Conditions & MeSH terms

• Disease Progression
• Myopia
• Myopia Progression

Intervention

Drug:
• Atropine
Compare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pupil size	Using computer scaling software. unit: millimeter(mm)	6 months
Other	accommodation	Using accommodometer to measuer accommodation. Unit: diopeter	6 months
Other	Questionnaire	Questionnaire written by patients and their parents about how many hours per week of near work (ex. computer/video game, reading, piano playing...) and outdoor activities, the compliance of atropine use, discomfort after atropine use (ex. photophobia or blurred vision when near work)	baseline and 6 months
Primary	Cycloplegic spherical refraction change	Cycloplegic spherical refraction change is the main indicator of the myopia progression.	1 year
Secondary	Axial length change	Axial length change is another indicator of the myopia progression.Using non-contact biometry. unit: millimeter(mm)	1 year