Myopia
Conditions
Brief summary
To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.
Interventions
DEVICERed Light Intervention
Repeated Low-Level Red-Light Therapy
DRUGAtropine
0.01% atropine
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Age at enrolment: 6-12 years; 2. At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less; 3. Anisometropia of 1.5 D or less; 4. The BCVA of distant vision is at least 0.8; 5. Myopia progressed more than 0.5D in the past year; 6. Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required; 7. Written informed consent of guardian and child.
Exclusion criteria
1. Strabismus, amblyopia or other ocular abnormalities; 2. Other systemic abnormalities; 3. Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye; 4. Atropine allergy; 5. Other situations that not suitable for participating in the trial as judged by the researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of axial length | at least 1 year | AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of spherical equivalent | at least 1 year | Spherical equivalent as measured by cycloplegia autorefraction |
| Change of choroidal thickness | at least 1 year | Choroidal thickness will be measured using SS-OCT |
| Change of uncorrected visual acuity | at least 1 year | Uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts. |
Countries
China
Contacts
Primary ContactJiannan Huang
Backup ContactXiangui He
Outcome results
None listed