Back to resultsThe Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control (AVO)
Primary Purpose
Myopia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
low-dose atropine eye drops
orthokeratology
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
Best corrected visual acuity less then 0.00 log MAR (minimum angle of resolution) units Cycloplegic SER of - 1.0 D or less in both eyes. An inter-eye cycloplegic SER difference of 1.00 D or more.
Exclusion Criteria:
Children with cycloplegic cylinder refraction of more than + 1.00 D or less than - 1.00 D.
History of binocular vision problems, including strabismus. History of known ocular disorders, including media opacities, macular dysgenesis, optic nerve hypoplasia, perinatal brain injury, buphthalmos, and retinopathy of prematurity.
History of medication use that might have affected the refractive results. Systemic or developmental problems that might have hindered refractive development.
Sites / Locations
- Visionly Eye HospitalRecruiting
- Parkway HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
orthokeratology group
low-dose atropine group
Arm Description
Outcomes
Primary Outcome Measures
Progression of myopia
The change of myopia (Ds)
Progression of axial length
The change of axial length (mm)
Secondary Outcome Measures
Full Information
NCT ID
NCT05478356
First Posted
July 26, 2022
Last Updated
July 26, 2022
Sponsor
Evidence Based Cataract Study Group
1. Study Identification
Unique Protocol Identification Number
NCT05478356
Brief Title
The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control
Acronym
AVO
Official Title
The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evidence Based Cataract Study Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Both orthokeratology and atropine eye drops are effective methods for myopia control, but few studies have compared them all together simultaneously. Therefore, the primary aim of the present study was to compare the effect of orthokeratology versus low-dose (0.01% and 0.02%) atropine on the control of myopia progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
orthokeratology group
Arm Type
Experimental
Arm Title
low-dose atropine group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
low-dose atropine eye drops
Intervention Description
low-dose atropine eye drops
Intervention Type
Device
Intervention Name(s)
orthokeratology
Intervention Description
orthokeratology, ortho-K lenses
Primary Outcome Measure Information:
Title
Progression of myopia
Description
The change of myopia (Ds)
Time Frame
1 year
Title
Progression of axial length
Description
The change of axial length (mm)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Best corrected visual acuity less then 0.00 log MAR (minimum angle of resolution) units Cycloplegic SER of - 1.0 D or less in both eyes. An inter-eye cycloplegic SER difference of 1.00 D or more.
Exclusion Criteria:
Children with cycloplegic cylinder refraction of more than + 1.00 D or less than - 1.00 D.
History of binocular vision problems, including strabismus. History of known ocular disorders, including media opacities, macular dysgenesis, optic nerve hypoplasia, perinatal brain injury, buphthalmos, and retinopathy of prematurity.
History of medication use that might have affected the refractive results. Systemic or developmental problems that might have hindered refractive development.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Zhou, M.D.
Phone
17898805125
Email
drzhoupeng@gmail.com
Facility Information:
Facility Name
Visionly Eye Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Zhou, M.D.
Phone
17898805125
Email
drzhoupeng@gmail.com
Facility Name
Parkway Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Zhou, M.D.
Phone
17898805125
Email
drzhoupeng@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control
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