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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03097198
• Other study ID #: 2016ZB080
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: March 24, 2017
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Wenzhou Medical University
• Contact: Lewei Tang, Doctor
• Phone: +86 15869627364
• Email: zhizhezhiwei[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• Plum-blossom Needle
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.

Drug:
• Tropicamide Eye Drops
Instill one drop in both eyes every night before bed.

Locations

Country	Name	City	State
China	School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of vision acuity	International Standard Visual Acuity Chart	Every 30 days for 150 days
Primary	Changes of cycloplegic refractive errors	Measured using subjective refraction	Every 30 days for 150 days
Secondary	Changes of accommodation responses		Every 30 days for 150 days
Secondary	Changes of accommodation facility		Every 30 days for 150 days
Secondary	Changes of ciliary body thickness		Every 30 days for 150 days
Secondary	Changes of axial length		Every 30 days for 150 days