Effect of Vision Therapy in Myopic Children With Poor Accommodative Response

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03006601
• Other study ID #: 2016AC2
• Status: Active, not recruiting
• Phase: N/A
• First received: October 28, 2016
• Last updated: December 28, 2016
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

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)

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No