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

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

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.

Study Overview

• Status: Unknown
• Conditions: Myopia
• Intervention / Treatment: Other: Plum-blossom Needle; Drug: 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 Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Recruiting
      • School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University
      • Contact: Lewei Tang, Doctor; Phone Number: +86 15869627364; Email: zhizhezhiwei@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PbN-TED; 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; 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.; Other Names: Double head dermal needles (HWATO, China); Drug: Tropicamide Eye Drops; Instill one drop in both eyes every night before bed.; Other Names: 6ml:30mg(0.5%)（FREDA, China）
Experimental: TED-PbN; 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; 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.; Other Names: Double head dermal needles (HWATO, China); Drug: Tropicamide Eye Drops; Instill one drop in both eyes every night before bed.; Other Names: 6ml:30mg(0.5%)（FREDA, China）

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Wenzhou Medical University
• Investigators: Study Director: Yuanbo Liang, Doctor, Clinical&Epidemiological Eye Research Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 31, 2017

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Juvenile; Plum-blossom needle
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Pharmaceutical Solutions; Mydriatics; Ophthalmic Solutions; Tropicamide
• Other Study ID Numbers: 2016ZB080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The IPD sharing plan is undecided yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No