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Low Concentration Atropine for Myopia Progression in School Children

Primary Purpose

Myopia Progression

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Atropine
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia Progression focused on measuring Myopia progression, Low concentration atropine

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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...)

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

0.01% Atropine

0.05% Atropine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2014
Last Updated
January 29, 2018
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02130167
Brief Title
Low Concentration Atropine for Myopia Progression in School Children
Official Title
Low Concentrations of Atropine for Controlling Myopia Progression in School Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia Progression
Keywords
Myopia progression, Low concentration atropine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.01% Atropine
Arm Type
Experimental
Arm Title
0.05% Atropine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Description
Compare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine
Primary Outcome Measure Information:
Title
Cycloplegic spherical refraction change
Description
Cycloplegic spherical refraction change is the main indicator of the myopia progression.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Axial length change
Description
Axial length change is another indicator of the myopia progression.Using non-contact biometry. unit: millimeter(mm)
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
pupil size
Description
Using computer scaling software. unit: millimeter(mm)
Time Frame
6 months
Title
accommodation
Description
Using accommodometer to measuer accommodation. Unit: diopeter
Time Frame
6 months
Title
Questionnaire
Description
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)
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Chang Wu, MD,PhD
Organizational Affiliation
Dep. of Ophthalmology, Kaohsiung Chang Gung Memorial Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

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Low Concentration Atropine for Myopia Progression in School Children

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