Effect of Vision Therapy in Myopic Children With Poor Accommodative Response

NCT ID: NCT03006601

Last Updated: 2016-12-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-12-31

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo group

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.

Group Type: PLACEBO_COMPARATOR

Office-based accommodative/vergence therapy

Intervention Type: OTHER

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)

Treatment group

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.

Group Type: EXPERIMENTAL

Office-based accommodative/vergence therapy

Intervention Type: OTHER

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)

Interventions

Office-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)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiang Chen

Study Principal Investigator Zhongshan Ophthalmic Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiang Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2016AC2

Identifier Type: -

Identifier Source: org_study_id