Clinical trial NCT02578407: Pilot Study of Accommodative/Vergence Therapy to Modify Accommodative Function in Children With Myopia
Official title: Pilot Study of Accommodative/Vergence Therapy to Modify Accommodative Function in Children With Myopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to determine the treatment effect of accommodative/vergence 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 prove accommodative/vergence therapy (AT) can normalize the accommodative function of myopic children.。 1.2 If the accommodation function of myopic children can be improved with AT therapy, the outcome will supply a basic for a randomized, multi-center clinic trail to determine the effectiveness of AT to slow the progression of myopia.
2. Hypothesis:

Accommodative/vergence therapy can normalize the accommodative functions of 8-12 years old Chinese myopic children.

Eligibility criteria: Inclusion Criteria:

Subjects enrolled in the trial must:

1. be within the age range of 8 to 12 years old inclusive;
2. -0.75d to -4.50dspherical equivalent by cycloplegic autorefraction in both eyes
3. astigmatism≤1.5d in both eyes；
4. anisometropia≤1.0d；
5. accommodation lag at near(33cm）in right eye by non-cycloplegic auto- refraction ≧1d;
6. have vision correctable to at least 0.8 or better in each eye.

Exclusion Criteria:

Subjects enrolled in the trial must NOT have:

1. current or prior use of progressive addition lens, bifocals, or contact lenses in either eye( prior or current use of single vision lens allowed)；
2. history of any of the following functional defects: strabismus, amblyopia, nystagmus；
3. history of diabetes or seizures；
4. history of any ocular systemic, or neuro-developmental condition that might influence refractive development；
5. use of ocular or systemic medications known to affect accommodation, such as atropine, pirenzepine, and anti-epileptic medications in recent 3 months；
6. history of any ocular surgery that might influence refractive development；
7. 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；
8. relocation anticipated for 3 years；
9. birth weight lower than 1250 grams（2lbs,12oz）；
10. siblings in the study.

Primary outcomes:
measure: Change in lag of accommodation assessed by open-field autorefractor from baseline visit at 6 months after 12 weekly vision therapies
timeFrame: Baseline visit, 7th visit(7 weeks after BL), 13th visit (13 weeks after BL), 14th visit(9months after BL, which is also 6months after vision therapies )
Secondary outcomes:
measure: Change in accommodative amplitude assessed by push-up technique from baseline visit at 6 months after 12 weekly vision therapies
timeFrame: Baseline visit, 7th visit(7 weeks after BL), 13th visit (13 weeks after BL), 14th visit(9months after BL, which is also 6months after vision therapies )
measure: Change in accommodative variability assessed by open-field autorefractor from baseline visit at 6 months after 12 weekly vision therapies
timeFrame: Baseline visit, 7th visit(7 weeks after BL), 13th visit (13 weeks after BL), 14th visit(9months after BL, which is also 6months after vision therapies )
measure: Change in accommodative facility assessed by flipper bar method from baseline visit at 6 months after 12 weekly vision therapies
timeFrame: Baseline visit, 7th visit(7 weeks after BL), 13th visit (13 weeks after BL), 14th visit(9months after BL, which is also 6months after vision therapies )
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, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: