Effect of Vision Therapy in Myopic Children With Poor Accommodative Response

Not Applicable

• Conditions: Myopia
• Interventions: Other: Office-based accommodative/vergence therapy

• Registration Number: NCT03006601
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-28
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-28
• Last Update Submitted: 2016-12-28
• Study First Posted: 2016-12-30
• Last Update Posted: 2016-12-30
• Primary Completion: 2017-02
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Office-based accommodative/vergence therapy	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 group	Office-based accommodative/vergence therapy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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
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)

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China