Clinical trial NCT03006601: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 34
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the change of Accommodative response is being assessed
timeFrame: 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:
measure: the changes of Accommodative amplitude is being assessed:
timeFrame: 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.
measure: the changes of Accommodative facility is being assessed:
timeFrame: 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.
measure: the changes of Cycloplegic objective refraction is being assessed:
timeFrame: 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.
measure: the changes of Axial length is being assessed:
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiang Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References: