NCT03006601 - Effect of Vision Therapy in Myopic Children With Poor Accommodative Response | Crick

Overview

This study aims to determine the treatment effect of vision therapy on myopic children by assessment of accommodative function before and after therapy.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

34

Conditions

Myopia

Interventions

Office-based accommodative/vergence therapyOTHER

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)

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China