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

Not Applicable

• Conditions: Myopia
• Interventions: Other: Plum-blossom Needle; Drug: Tropicamide Eye Drops

• Registration Number: NCT03097198
• Lead Sponsor: Wenzhou Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-12
• Status Verified: 2017-03
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-24
• Last Update Submitted: 2017-03-24
• Study First Posted: 2017-03-31
• Last Update Posted: 2017-03-31
• Primary Completion: 2018-01
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PbN-TED	Tropicamide Eye Drops	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	Tropicamide Eye Drops	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.
PbN-TED	Plum-blossom Needle	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	Plum-blossom Needle	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.

Primary Outcome Measures

Name	Time	Method
Changes of vision acuity	Every 30 days for 150 days	International Standard Visual Acuity Chart
Changes of cycloplegic refractive errors	Every 30 days for 150 days	Measured using subjective refraction

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China