Pilot Study of Accommodative/Vergence Therapy to Modify Accommodative Function in Children With Myopia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Sun Yat-sen University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in lag of accommodation assessed by open-field autorefractor from baseline visit at 6 months after 12 weekly vision therapies
- Last Updated
- 10 years ago
Overview
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.
Investigators
Xiang Chen
Head, Operation office of Clinical Research Center Institution of Drug Clinical Trials,Zhongshan Opthalmic Center of Sun Yat-sen University
Sun Yat-sen University
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；
- •accommodation lag at near(33cm）in right eye by non-cycloplegic auto- refraction ≧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 progressive addition lens, bifocals, or contact lenses in either eye( prior or current use of single vision lens 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 known to affect accommodation, such as 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 3 years；
- •birth weight lower than 1250 grams（2lbs,12oz）；
Outcomes
Primary Outcomes
Change in lag of accommodation assessed by open-field autorefractor from baseline visit at 6 months after 12 weekly vision therapies
Time Frame: 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 )
We will measure the lag of accommodation objectively in right eye at 33 cm by using open-field autorefractor. An average of 10 static measurements will be recorded in spherical equivalent dioptric power.
Secondary Outcomes
- Change in accommodative facility assessed by flipper bar method from baseline visit at 6 months after 12 weekly vision therapies(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 ))
- Change in accommodative amplitude assessed by push-up technique from baseline visit at 6 months after 12 weekly vision therapies(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 ))
- Change in accommodative variability assessed by open-field autorefractor from baseline visit at 6 months after 12 weekly vision therapies(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 ))