Myopia
Conditions
Keywords
Myopia, Myopia control, Atropine, Electroretinogram, Multifocal Electroretinogram
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.
Interventions
DRUGAtropine (0.01%)
tropical application
DRUGArtificial tear
tropical application
Sponsors
The University of Hong Kong
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Changes in Refractive Error (SER) | 18 months | Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Change in Axial Length | 18 months | Annualized change in axial length after receiving the 0.01 atropine or artificial tears up to 18 months |
Countries
Hong Kong
Participant flow
Recruitment details
Recruitment period: Feb 2018 - Oct 2018 Location: HK PolyU Optometry clinic
Participants by arm
| Arm | Count |
|---|---|
| Atropine 0.01% Group receiving atropine treatment for 18 months
Atropine (0.01%): tropical application | 36 |
| Artifical Tear Group receiving placebo for 18 months
Artificial tear: tropical application | 35 |
| Total | 71 |
Baseline characteristics
| Characteristic | Atropine 0.01% | Artifical Tear | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 34 Participants | 27 Participants | 61 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Axial length | 24.17 mm STANDARD_DEVIATION 0.79 | 24.09 mm STANDARD_DEVIATION 0.74 | 24.13 mm STANDARD_DEVIATION 0.76 |
| Electroretinogram | 41.65 nV/deg^2 STANDARD_DEVIATION 24.4 | 50.01 nV/deg^2 STANDARD_DEVIATION 27.75 | 45.16 nV/deg^2 STANDARD_DEVIATION 25.45 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Refractive errors | -1.88 Dioptre STANDARD_DEVIATION 1.08 | -1.74 Dioptre STANDARD_DEVIATION 0.71 | -1.8 Dioptre STANDARD_DEVIATION 0.95 |
| Region of Enrollment Hong Kong | 34 participants | 27 participants | 61 participants |
| Sex: Female, Male Female | 17 Participants | 13 Participants | 30 Participants |
| Sex: Female, Male Male | 17 Participants | 14 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 27 |
| other Total, other adverse events | 0 / 34 | 0 / 27 |
| serious Total, serious adverse events | 0 / 34 | 0 / 27 |
Outcome results
Primary
Annualized Changes in Refractive Error (SER)
Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months
Time frame: 18 months
Population: Annualized changes in refractive error (SER)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atropine 0.01% | Annualized Changes in Refractive Error (SER) | -0.70 Dioptre/year | Standard Deviation 0.39 |
| Artifical Tear | Annualized Changes in Refractive Error (SER) | -0.66 Dioptre/year | Standard Deviation 0.41 |
Secondary
Annualized Change in Axial Length
Annualized change in axial length after receiving the 0.01 atropine or artificial tears up to 18 months
Time frame: 18 months
Population: annualized change in axial length
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atropine 0.01% | Annualized Change in Axial Length | 0.3 mm/year | Standard Deviation 0.22 |
| Artifical Tear | Annualized Change in Axial Length | 0.32 mm/year | Standard Deviation 0.16 |