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Low Concentration Atropine for Myopia Progression in School Children

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02130167
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
60
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Low Concentrations of Atropine for Controlling Myopia Progression in School Children
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 0.01% Atropine

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
Active Comparator: 0.05% Atropine

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

Outcome Measures

Primary Outcome Measures

  1. Cycloplegic spherical refraction change [1 year]

    Cycloplegic spherical refraction change is the main indicator of the myopia progression.

Secondary Outcome Measures

  1. Axial length change [1 year]

    Axial length change is another indicator of the myopia progression.Using non-contact biometry. unit: millimeter(mm)

Other Outcome Measures

  1. pupil size [6 months]

    Using computer scaling software. unit: millimeter(mm)

  2. accommodation [6 months]

    Using accommodometer to measuer accommodation. Unit: diopeter

  3. Questionnaire [baseline and 6 months]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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...)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan 833

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Pei-Chang Wu, MD,PhD, Dep. of Ophthalmology, Kaohsiung Chang Gung Memorial Hospital, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02130167
Other Study ID Numbers:
  • CMRPG8C0601
First Posted:
May 5, 2014
Last Update Posted:
Jan 30, 2018
Last Verified:
Jan 1, 2018
Keywords provided by Chang Gung Memorial Hospital
Myopia progression
Low concentration atropine
Additional relevant MeSH terms:
Myopia
Disease Progression
Atropine

Study Results

No Results Posted as of Jan 30, 2018