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The purpose of this study is to determine whether plum-blossom needle is effective in the treatment of juvenile myopia and compare the efficacy with Tropicamide Eye Drops.
Plum-blossom needle is a historical treatment technology of Traditional Chinese Medicine, and has been applied to ophthalmic diseases, such as myopia and glaucoma, for nearly one hundred years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PbN-TED | Experimental | Treated with plum-blossom needle first for 10 times during 20 days, followed with a one-month wash-out period and a 10-day period with Tropicamide Eye Drops. |
|
| TED-PbN | Experimental | Treated with Tropicamide Eye Drops for 10 days first, followed with a one-month wash-out period and 10 times of plum-blossom needle treatment for 20 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plum-blossom Needle | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of vision acuity | International Standard Visual Acuity Chart | Every 30 days for 150 days |
| Changes of cycloplegic refractive errors | Measured using subjective refraction | Every 30 days for 150 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of accommodation responses | Every 30 days for 150 days | |
| Changes of accommodation facility | Every 30 days for 150 days | |
| Changes of ciliary body thickness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lewei Tang, Doctor | Contact | +86 15869627364 | zhizhezhiwei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuanbo Liang, Doctor | Clinical&Epidemiological Eye Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325027 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32242400 | Derived | Chen L, Liang Y, Xu M, Zheng J, Yu H, Tang L. Effect of plum-blossom needling versus tropicamide eye drops on adolescent myopia: protocol for a randomized crossover trial. J Tradit Chin Med. 2020 Apr;40(2):333-339. |
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The IPD sharing plan is undecided yet.
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
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| Tropicamide Eye Drops | Drug | Instill one drop in both eyes every night before bed. |
|
|
| Every 30 days for 150 days |
| Changes of axial length | Every 30 days for 150 days |