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This study aims to determine the treatment effect of vision therapy on myopic children by assessment of accommodative function before and after therapy.
Specific aims of the proposed clinical trial:
1.1 To provide a definitive proof that vision therapy (VT) can improve the accommodative function of myopic children by comparing the results from treatment group to placebo group.
1.2 To minimize the influences of confounding variables by randomly assigning the intervention.
1.3 To observe the longitudinal effects of VT on accommodation system and its effect on axial length.
Hypothesis:
VT can improve the accommodative functions of 8-12 years old Chinese myopic children with poor accommodative response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | After enrollment, patients will be randomized into either treatment group or placebo group. Patients will receive placebo procedure which were designed to look like real vergence/accommodative therapy procedures yet not stimulate vergence, accommodation, of fine saccadic eye movement skills beyond normal daily visual activities. Office-based procedures (60 minutes per visit, one time per week, 12 weeks) and home procedures (15 minutes each time, five times per week, 12 weeks) will be provided to patients. |
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| Treatment group | Experimental | After enrollment, patients will be randomized into either treatment group or placebo group. Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks) will be provided to patients of treatment group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Office-based accommodative/vergence therapy | Other | Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| the change of Accommodative response is being assessed | we will use objective measures from open-field auto refractor. | At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT. |
| Measure | Description | Time Frame |
|---|---|---|
| the changes of Accommodative amplitude is being assessed: | we will use subjective measures from accommodative rod(push up method) | At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT. |
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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 | Affiliation | Role |
|---|---|---|
| Xiang Chen, PhD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| the changes of Accommodative facility is being assessed: | we will use subjective measures from lens flipper | At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT. |
| the changes of Cycloplegic objective refraction is being assessed: | we will use objective measures from open-field auto refractor. | At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT. |
| the changes of Axial length is being assessed: | we will use objective measures from IOL-Master | At least 15 visits (Screening visit, baseline visit, 12 weekly visits and 6 months after therapy). Eye examination will only be performed at screening visit, baseline visit, 6 week follow up, 12 week follow up,6 months after VT. |