NCT03097198

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

March 20, 2017

Last Update Submit

March 24, 2017

Conditions

Myopia

Keywords

JuvenileTraditional Chinese MedicinePlum-blossom needle

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

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.

Other: Plum-blossom NeedleDrug: 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.

Other: Plum-blossom NeedleDrug: Tropicamide Eye Drops

Interventions

Plum-blossom NeedleOTHER

* 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.

Also known as: Double head dermal needles (HWATO, China)
PbN-TEDTED-PbN
Tropicamide Eye DropsDRUG

Instill one drop in both eyes every night before bed.

Also known as: 6ml:30mg(0.5%)（FREDA, China）
PbN-TEDTED-PbN

Eligibility Criteria

Age8 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32242400DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Yuanbo Liang, Doctor

    Clinical&Epidemiological Eye Research Center

    STUDY DIRECTOR

Central Study Contacts

Lewei Tang, Doctor

CONTACT

+86 15869627364zhizhezhiwei@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 31, 2017

Study Start

December 1, 2016

Primary Completion

January 1, 2018

Study Completion

December 1, 2018

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations

CN(1)