Pilot Study of Accommodative/Vergence Therapy to Modify Accommodative Function in Children With Myopia (ACC)

Sun Yat-sen University

Status: Unknown

Conditions: Myopia

Treatments: Other: accommodative/vergence therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02578407

2015ACC

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Accommodative/Vergence Therapy

Experimental group

Description:

Accommodative/Vergence Therapy. No drug involved.

Treatment:

Other: accommodative/vergence therapy