Eye Drops Study for Myopia Control in Schoolchildren
Primary Purpose
Myopia, Progressive, Atropine Allergy
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Myopia, Progressive focused on measuring myopia, schoolchildren, atropine, allergy, eye drops, outdoor, near work
Eligibility Criteria
Inclusion Criteria:
- Myopia diagnosed with the spherical equivalent refraction at least -0.5 diopter (D)
- Must be able to use eye drops
Exclusion Criteria:
- astigmatism -1.50 D or greater
- strabismus
- amblyopia
- cataract
- glaucoma
- any ocular diseases ocular surgery
- history of systemic diseases (ex. asthma, heart disease...)
- contact lenses user
- orthokeratology user
Sites / Locations
- Kaohsiung Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
0.01% atropine
0.005% atropine
0.25% Ketorolac
0.01% atropine plus 0.25% Ketorolac
0.005% atropine plus 0.25% Ketorolac
Arm Description
children who received 0.01% atropine for myopia
children who received 0.005% atropine for myopia
children who received 0.25% Ketorolac for myopia
children who received 0.01% atropine plus 0.25% Ketorolac for myopia
children who received 0.005% atropine plus 0.25% Ketorolac for myopia
Outcomes
Primary Outcome Measures
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter)
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) is the main indicator of the myopia progression.
Axial length change (mm) measured by non-contact biometry
Axial length change (mm) measured by non-contact biometry is another indicator of the myopia progression.
Secondary Outcome Measures
Intraocular pressure (mmHg) by non-contact tonometer
measures Intraocular pressure (mmHg) by non-contact tonometer
Accommodation (diopter) by accommodometer
Accommodation change (diopter) by accommodometer is another indicator of the myopia progression.
Pupil size (mm) by electronic rule
measures Pupil size (mm) by electronic rule
Anterior chamber depth (mm) measured by non-contact biometry
measures Anterior chamber depth (mm) measured by non-contact biometry
Posterior chamber depth (mm) measured by non-contact biometry
measures Posterior chamber depth (mm) measured by non-contact biometry
Full Information
NCT ID
NCT03402100
First Posted
January 4, 2018
Last Updated
January 16, 2018
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03402100
Brief Title
Eye Drops Study for Myopia Control in Schoolchildren
Official Title
Eye Drops Study for Myopia Control in Schoolchildren
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2014 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The myopia prevalence in schoolchildren is high in Taiwan. The myopia progression is fast in children and often associated high myopia in later life. This prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops.
Detailed Description
Myopia onset earlier in children who would suffer a high degree of myopia in the future adulthood.and higher risk for retinal detachment, macular degeneration, and even blindness. In Taiwan, myopia macular degeneration is the first place of irreversible blind cause in the elderly. The evidence based medicine shows atropine is the most effective treatment for the progression of myopia so far, but the side effects including photophobia and near blurred vision often disturbing patients and resulting poor compliance and high drop-out rate.
Recently, the studies from Taiwan and Singapore showed that low concentrations of atropine (0.05% or 0.01%) can effectively inhibit the myopia progression, reduce the symptoms of photophobia, and to achieve favorable myopia control. Previous study found that myopia and allergic conjunctivitis and inflammation were related. The investigators designed a prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops. Due to environmental factors such as near work, after school class and outdoor activity are also great associated with myopia, the questionnaires also are collected in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Progressive, Atropine Allergy
Keywords
myopia, schoolchildren, atropine, allergy, eye drops, outdoor, near work
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0.01% atropine
Arm Type
Experimental
Arm Description
children who received 0.01% atropine for myopia
Arm Title
0.005% atropine
Arm Type
Experimental
Arm Description
children who received 0.005% atropine for myopia
Arm Title
0.25% Ketorolac
Arm Type
Experimental
Arm Description
children who received 0.25% Ketorolac for myopia
Arm Title
0.01% atropine plus 0.25% Ketorolac
Arm Type
Experimental
Arm Description
children who received 0.01% atropine plus 0.25% Ketorolac for myopia
Arm Title
0.005% atropine plus 0.25% Ketorolac
Arm Type
Experimental
Arm Description
children who received 0.005% atropine plus 0.25% Ketorolac for myopia
Intervention Type
Drug
Intervention Name(s)
eye drops
Intervention Description
children who received daily eye drops for myopia
Primary Outcome Measure Information:
Title
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter)
Description
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) is the main indicator of the myopia progression.
Time Frame
1 year
Title
Axial length change (mm) measured by non-contact biometry
Description
Axial length change (mm) measured by non-contact biometry is another indicator of the myopia progression.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Intraocular pressure (mmHg) by non-contact tonometer
Description
measures Intraocular pressure (mmHg) by non-contact tonometer
Time Frame
1 year
Title
Accommodation (diopter) by accommodometer
Description
Accommodation change (diopter) by accommodometer is another indicator of the myopia progression.
Time Frame
1 year
Title
Pupil size (mm) by electronic rule
Description
measures Pupil size (mm) by electronic rule
Time Frame
1 year
Title
Anterior chamber depth (mm) measured by non-contact biometry
Description
measures Anterior chamber depth (mm) measured by non-contact biometry
Time Frame
1 year
Title
Posterior chamber depth (mm) measured by non-contact biometry
Description
measures Posterior chamber depth (mm) measured by non-contact biometry
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Questionnaire
Description
Record by patients and their parents about how many hours per week of near work (ex. computer/video game,cell phone,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
1 year
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 diagnosed with the spherical equivalent refraction at least -0.5 diopter (D)
Must be able to use eye drops
Exclusion Criteria:
astigmatism -1.50 D or greater
strabismus
amblyopia
cataract
glaucoma
any ocular diseases ocular surgery
history of systemic diseases (ex. asthma, heart disease...)
contact lenses user
orthokeratology user
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Chang Wu, MD
Email
wooopc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Chang Wu, MD
Organizational Affiliation
No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Chang Wu, MD
12. IPD Sharing Statement
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Eye Drops Study for Myopia Control in Schoolchildren
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