Effect of Vision Therapy in Myopic Children With Poor Accommodative Response

Sun Yat-sen University

Status: Unknown

Conditions: Myopia

Treatments: Other: Office-based accommodative/vergence therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03006601

2016AC2

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

After enrollment, patients will be randomized into either treatment group or placebo group. Patients will receive placebo procedure which were designed to look like real vergence/accommodative therapy procedures yet not stimulate vergence, accommodation, of fine saccadic eye movement skills beyond normal daily visual activities. Office-based procedures (60 minutes per visit, one time per week, 12 weeks) and home procedures (15 minutes each time, five times per week, 12 weeks) will be provided to patients.

Treatment:

Other: Office-based accommodative/vergence therapy

Treatment group

Experimental group

Description:

After enrollment, patients will be randomized into either treatment group or placebo group. 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) will be provided to patients of treatment group.

Treatment:

Other: Office-based accommodative/vergence therapy