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This study aims to determine the treatment effect of accommodative/vergence therapy on myopic children by assessment of accommodative function before and after therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accommodative/Vergence Therapy | Experimental | Accommodative/Vergence Therapy. No drug involved. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| accommodative/vergence therapy | Other | 12 weekly accommodative/vergence therapies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in lag of accommodation assessed by open-field autorefractor from baseline visit at 6 months after 12 weekly 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. | 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 | Description | Time Frame |
|---|---|---|
| Change in accommodative amplitude assessed by push-up technique from baseline visit at 6 months after 12 weekly 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. | 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 ) |
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Inclusion Criteria:
Subjects enrolled in the trial must:
Exclusion Criteria:
Subjects enrolled in the trial must NOT have:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Chen, Ph.D | Contact | 87334687 | 87334687 | chen1094@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiang Chen, Ph.D | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Change in accommodative variability assessed by open-field autorefractor from baseline visit at 6 months after 12 weekly 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. | 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 facility assessed by flipper bar method from baseline visit at 6 months after 12 weekly 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. | 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 ) |