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Effect of Vision Therapy in Myopic Children With Poor Accommodative Response

Primary Purpose

Myopia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Office-based accommodative/vergence therapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Zhongshan Ophthalmic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo group

Treatment group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 28, 2016
Last Updated
December 28, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03006601
Brief Title
Effect of Vision Therapy in Myopic Children With Poor Accommodative Response
Official Title
Effect of Vision Therapy on Accommodation in Myopic Chinese Children With Poor Accommodative Response: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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. Hypothesis: VT can improve the accommodative functions of 8-12 years old Chinese myopic children with poor accommodative response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Treatment group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Office-based accommodative/vergence therapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
the change of Accommodative response is being assessed
Description
we will use objective measures from open-field auto refractor.
Time Frame
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 Measure Information:
Title
the changes of Accommodative amplitude is being assessed:
Description
we will use subjective measures from accommodative rod(push up method)
Time Frame
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.
Title
the changes of Accommodative facility is being assessed:
Description
we will use subjective measures from lens flipper
Time Frame
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.
Title
the changes of Cycloplegic objective refraction is being assessed:
Description
we will use objective measures from open-field auto refractor.
Time Frame
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.
Title
the changes of Axial length is being assessed:
Description
we will use objective measures from IOL-Master
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Chen, PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Vision Therapy in Myopic Children With Poor Accommodative Response

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