Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia: A Cross-over Single-blind Randomized Study

Conditions
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Myopia

Intervention / Treatment
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* Other: Plum-blossom Needle
* Drug: Tropicamide Eye Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The result of retinoscopy is myopic refractive error, near visual acuity and other visual functions must be normal Distance visual acuity can be corrected to normal using negative spherical or cylindrical lenses Myopia diopter spherical lenses must be ≤-3.00 D which measured under cycloplegia Subjects must be between 8 and 20 years of age Exclusion Criteria: Diopter spherical lenses be >-3.00 D , or uncorrected distance visual acuity <0.1, or pathologic myopia with eye complications Diopter spherical lense ≥1.50 D or cylindrical lenses ≥1.00 D, as measured under cycloplegia The affected eyes have other diseases which affect the determination of acupuncture efficacy Subjects with serious systemic diseases, such as cerebrovascular, liver, kidney, hematopoietic system, and psychiatric diseases Longterm use of other related drugs or treatments, which have not been terminated Parents or subjects refuse to participate this trial Participating other ongoing clinical trials

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PbN-TED<br>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. | Other: Plum-blossom Needle<br>* acupoint selection: Zhengguang 1, Zhengguang 2, GB20, GV14, LI4. plum-blossom needle manipulation methods: After the skin has been wiped with 75 % alcohol, plum-blossom needles will be tapped perpendicularly on the skin at the selected acupoints with wrist force and then lifted immediately. Each point will be tapped repeatedly for 20 to 50 times and both sides of cervical vertebra and temporal region, Suprao-infraorbital margin will be tapped repeatedly. Acupuncturists should tap the points gently to make patients feel only a little pain and stop when the skin gets flushed but is not bleeding.<br>* Other names: Double head dermal needles (HWATO, China);Drug: Tropicamide Eye Drops<br>* Instill one drop in both eyes every night before bed.<br>* Other names: 6ml:30mg(0.5%)（FREDA, China）;|
| Experimental: TED-PbN<br>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. | Other: Plum-blossom Needle<br>* acupoint selection: Zhengguang 1, Zhengguang 2, GB20, GV14, LI4. plum-blossom needle manipulation methods: After the skin has been wiped with 75 % alcohol, plum-blossom needles will be tapped perpendicularly on the skin at the selected acupoints with wrist force and then lifted immediately. Each point will be tapped repeatedly for 20 to 50 times and both sides of cervical vertebra and temporal region, Suprao-infraorbital margin will be tapped repeatedly. Acupuncturists should tap the points gently to make patients feel only a little pain and stop when the skin gets flushed but is not bleeding.<br>* Other names: Double head dermal needles (HWATO, China);Drug: Tropicamide Eye Drops<br>* Instill one drop in both eyes every night before bed.<br>* Other names: 6ml:30mg(0.5%)（FREDA, China）;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Every 30 days for 150 days | 
| Changes of axial length |  | Every 30 days for 150 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Juvenile, Traditional Chinese Medicine, Plum-blossom needle