Effect of Vision Therapy in Myopic Children With Poor Accommodative Response

Effect of Vision Therapy on Accommodation in Myopic Chinese Children With Poor Accommodative Response: A Randomized Clinical Trial

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

Study Overview

• Status: Unknown
• Conditions: Myopia
• Intervention / Treatment: Other: Office-based accommodative/vergence 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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Other: 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)
Experimental: 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.	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of Accommodative response is being assessed	we will use objective measures from open-field auto refractor.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the changes of Accommodative amplitude is being assessed:	we will use subjective measures from accommodative rod(push up method)	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.
the changes of Accommodative facility is being assessed:	we will use subjective measures from lens flipper	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.
the changes of Cycloplegic objective refraction is being assessed:	we will use objective measures from open-field auto refractor.	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.
the changes of Axial length is being assessed:	we will use objective measures from IOL-Master	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.

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Xiang Chen, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimate): December 30, 2016

Study Record Updates

• Last Update Posted (Estimate): December 30, 2016
• Last Update Submitted That Met QC Criteria: December 28, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 2016AC2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED