Myopia
Conditions
Brief summary
This study aims to determine the treatment effect of vision therapy on myopic children by assessment of accommodative function before and after therapy.
Detailed description
1. Specific aims of the proposed clinical trial: 1.1 To provide a definitive proof that vision therapy (VT) can improve the accommodative function of myopic children by comparing the results from treatment group to placebo group. 1.2 To minimize the influences of confounding variables by randomly assigning the intervention. 1.3 To observe the longitudinal effects of VT on accommodation system and its effect on axial length. 2. Hypothesis: VT can improve the accommodative functions of 8-12 years old Chinese myopic children with poor accommodative response.
Interventions
OTHEROffice-based accommodative/vergence therapy
Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks)
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects enrolled in the trial must: * be within the age range of 8 to 12 years old inclusive * -0.75D to -4.50Dspherical equivalent by cycloplegic autorefraction in both eyes * astigmatism≤1.5D in both eyes * anisometropia≤1.0D * monocular accommodation lag at near(33cm)in right eye by non-cycloplegic autorefraction≧1D * have vision correctable to at least 0.8 or better in each eye.
Exclusion criteria
Subjects enrolled in the trial must NOT have: * current or prior use of PALs, bifocals, or contact lenses in either eye( prior or current use of SVLs allowed) * history of any of the following functional defects: strabismus, amblyopia, nystagmus * history of diabetes or seizures * history of any ocular systemic, or neuro-developmental condition that might influence refractive development * use of ocular or systemic medications containing atropine, pirenzepine, and anti-epileptic medications in recent 3 months * history of any ocular surgery that might influence refractive development * developmental disability, attention deficit hyperactivity disorder(ADHD), or learning disability diagnosis in children that in the investigator's discretion would interfere with office-based treatment * relocation anticipated for 1 year * birth weight lower than 1250 grams（2lbs,12oz） * siblings in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change of Accommodative response is being assessed | At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT. | we will use objective measures from open-field auto refractor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the changes of Accommodative amplitude is being assessed: | At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT. | we will use subjective measures from accommodative rod(push up method) |
| the changes of Accommodative facility is being assessed: | At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT. | we will use subjective measures from lens flipper |
| the changes of Cycloplegic objective refraction is being assessed: | At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT. | we will use objective measures from open-field auto refractor. |
| the changes of Axial length is being assessed: | At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT. | we will use objective measures from IOL-Master |
Countries
China
Outcome results
None listed