Back to resultsTopical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Atropine (0.01%)
Artificial tear
Sponsored by
About this trial
This is an interventional prevention trial for Myopia focused on measuring Myopia, Myopia control, Atropine, Electroretinogram, Multifocal Electroretinogram
Eligibility Criteria
Inclusion Criteria:
- Age between 7 and 10 years
- Good general health and no family history of ocular diseases
- No current or history of epilepsy or asthma
- Myopia : -0.50 to -1.00 D (inclusive, both eyes)
- Astigmatism : ≤ 0.50 D
- No hyperopia, amblyopia or strabismus
- No reported ocular eye diseases or disorders
- No drug allergy
Sites / Locations
- School of Optometry, Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Atropine 0.01%
Artifical tear
Arm Description
Group receiving atropine treatment for 18 months
Group receiving placebo for 18 months
Outcomes
Primary Outcome Measures
Refractive errors
Refractive errors
Secondary Outcome Measures
Axial length
Size of the eyeball
Full Information
NCT ID
NCT03374306
First Posted
December 11, 2017
Last Updated
August 24, 2021
Sponsor
The Hong Kong Polytechnic University
Collaborators
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03374306
Brief Title
Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate
Official Title
Treatment Effect of Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate as Classified by Electro-retinal Responses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our project is a 24-month longitudinal randomized controlled trial that aims to investigate the myopia development after topical application of 0.01% atropine in children with either fast or slow myopia progression classified according to their initial electro-retinal responses. This will help elucidate the effectiveness of using low concentration atropine for myopia control in children with different myopia progression rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, Myopia control, Atropine, Electroretinogram, Multifocal Electroretinogram
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
ParticipantInvestigator
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atropine 0.01%
Arm Type
Experimental
Arm Description
Group receiving atropine treatment for 18 months
Arm Title
Artifical tear
Arm Type
Placebo Comparator
Arm Description
Group receiving placebo for 18 months
Intervention Type
Drug
Intervention Name(s)
Atropine (0.01%)
Intervention Description
tropical application
Intervention Type
Drug
Intervention Name(s)
Artificial tear
Intervention Description
tropical application
Primary Outcome Measure Information:
Title
Refractive errors
Description
Refractive errors
Time Frame
up to 18 months
Secondary Outcome Measure Information:
Title
Axial length
Description
Size of the eyeball
Time Frame
up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 7 and 10 years
Good general health and no family history of ocular diseases
No current or history of epilepsy or asthma
Myopia : -0.50 to -1.00 D (inclusive, both eyes)
Astigmatism : ≤ 0.50 D
No hyperopia, amblyopia or strabismus
No reported ocular eye diseases or disorders
No drug allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry HL CHAN, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Optometry, Hong Kong Polytechnic University
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate
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