Effect of Vision Therapy in Myopic Children With Poor Accommodative Response

NCT03006601 | Unknown

• 1 other identifier: 2016AC2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Treatment group

EXPERIMENTAL

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

Interventions

Office-based accommodative/vergence therapy 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)

Placebo group; Treatment group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects enrolled in the trial must:
• be within the age range of 8 to 12 years old inclusive
• D 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Xiang Chen, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: December 30, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 30, 2016

Record last verified: 2016-12

Locations

CN (1)