ACC: Pilot Study of Accommodative/Vergence Therapy to Modify Accommodative Function in Children With Myopia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
- 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.
- Hypothesis:
Accommodative/vergence therapy can normalize the accommodative functions of 8-12 years old Chinese myopic children.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Accommodative/Vergence Therapy Accommodative/Vergence Therapy. No drug involved. |
Other: accommodative/vergence therapy
12 weekly accommodative/vergence therapies
|
Outcome Measures
Primary Outcome Measures
- Change in lag of accommodation 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 )]
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 Outcome Measures
- 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 )]
We will measure the accommodative amplitude in right eye by using push-up technique with the use of Gulden accommodation rule. An average of 3 measurements will be recorded in spherical dioptric power.
- 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 )]
We will measure the level of fluctuation in lag of accommodation at 33 cm objectively by using open-field autorefractor. A 1 minute continuous measurement will be taken in right eye. The unit of measurement is spherical equivalent dioptric power.
- 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 )]
We will measure the accommodative facility at 40 cm by flipper bar method using a ±2.00 diopters lens flipper. 1 measurement will be taken in right eye. The unit of measurement is cycles per minute.
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects enrolled in the trial must:
-
be within the age range of 8 to 12 years old inclusive;
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-0.75d to -4.50dspherical equivalent by cycloplegic autorefraction in both eyes
-
astigmatism≤1.5d in both eyes；
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anisometropia≤1.0d；
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accommodation lag at near(33cm）in right eye by non-cycloplegic auto- refraction ≧1d;
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have vision correctable to at least 0.8 or better in each eye.
Exclusion Criteria:
Subjects enrolled in the trial must NOT have:
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current or prior use of progressive addition lens, bifocals, or contact lenses in either eye( prior or current use of single vision lens allowed)；
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history of any of the following functional defects: strabismus, amblyopia, nystagmus；
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history of diabetes or seizures；
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history of any ocular systemic, or neuro-developmental condition that might influence refractive development；
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use of ocular or systemic medications known to affect accommodation, such as atropine, pirenzepine, and anti-epileptic medications in recent 3 months；
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history of any ocular surgery that might influence refractive development；
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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；
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relocation anticipated for 3 years；
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birth weight lower than 1250 grams（2lbs,12oz）；
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siblings in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Ophthalmic Center | Guangzhou | Guangdong | China | 510080 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Xiang Chen, Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015ACC