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

Primary Purpose

Myopia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Plum-blossom Needle
Tropicamide Eye Drops
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring Juvenile, Traditional Chinese Medicine, Plum-blossom needle

Eligibility Criteria

8 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PbN-TED

TED-PbN

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes of vision acuity
International Standard Visual Acuity Chart
Changes of cycloplegic refractive errors
Measured using subjective refraction

Secondary Outcome Measures

Changes of accommodation responses
Changes of accommodation facility
Changes of ciliary body thickness
Changes of axial length

Full Information

First Posted
March 20, 2017
Last Updated
March 24, 2017
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03097198
Brief Title
Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia
Official Title
Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia: A Cross-over Single-blind Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Juvenile, Traditional Chinese Medicine, Plum-blossom needle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PbN-TED
Arm Type
Experimental
Arm Description
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.
Arm Title
TED-PbN
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Plum-blossom Needle
Other Intervention Name(s)
Double head dermal needles (HWATO, China)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tropicamide Eye Drops
Other Intervention Name(s)
6ml:30mg(0.5%)（FREDA, China）
Intervention Description
Instill one drop in both eyes every night before bed.
Primary Outcome Measure Information:
Title
Changes of vision acuity
Description
International Standard Visual Acuity Chart
Time Frame
Every 30 days for 150 days
Title
Changes of cycloplegic refractive errors
Description
Measured using subjective refraction
Time Frame
Every 30 days for 150 days
Secondary Outcome Measure Information:
Title
Changes of accommodation responses
Time Frame
Every 30 days for 150 days
Title
Changes of accommodation facility
Time Frame
Every 30 days for 150 days
Title
Changes of ciliary body thickness
Time Frame
Every 30 days for 150 days
Title
Changes of axial length
Time Frame
Every 30 days for 150 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lewei Tang, Doctor
Phone
+86 15869627364
Email
zhizhezhiwei@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanbo Liang, Doctor
Organizational Affiliation
Clinical&Epidemiological Eye Research Center
Official's Role
Study Director
Facility Information:
Facility Name
School of Ophthalmology and Optometry, Eye Hospital, Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lewei Tang, Doctor
Phone
+86 15869627364
Email
zhizhezhiwei@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The IPD sharing plan is undecided yet.
Citations:
PubMed Identifier
32242400
Citation
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.
Results Reference
derived

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

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