Myopia Control by Combining Auricular Acupoint and Atropi... | NCT00457717

Studies
Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops

NCT00457717

Sponsor

China Medical University, China

Status

Completed

Last Update Posted

Apr 6, 2007Estimated

Enrollment

Phase

Phase 1

Conditions

Myopia

Interventions

0.25 % atropine
0.5 % atropine
0.25 % atropine+auricular acupoints

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

Jul 2006Actual

First Submitted Date

Apr 5, 2007

First Submission Date that Met QC Criteria

Apr 5, 2007

First Posted Date

Apr 6, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2007

Last Update Posted Date

Apr 6, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression.

Detailed Description

A total of 64 school-aged children with myopia, fulfilling eligibility criteria, were recruited. They were randomly assigned to three arms:

21 treated with the 0.25 % atropine each night (0.25A).
20 treated with the 0.5 % atropine each night (0.5A).
23 treated with 0.25 % atropine each night together with stimulation of auricular acupoints(0.25A+E).

This protocol was proceeded for at least 6 months.The differences in post-treatment effects of these three groups were statistically accessed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
the progression of myopia degree, axial length elongation of eye

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all included patients, age from 6 to 15 years, had myopia (spherical equivalent > -0.5 D) after cycloplegic refraction,
The astigmatism and anisometropia were less than 2.0 D,
IOP was less than 21 mmHg.

Exclusion Criteria:

the presence of related disease such as infection, ulceration, eyelid disease, ocular and auricular disorders,
individuals with amblyopia or strabismus,
individuals received any other therapies in the period of study,
individuals suffering some sort of haemostasis disorder,
individuals did not follow the treatment (eyedrops and/or stimulation of auricular acupoints) over seven days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shih-Liang Chang, PhD	China Medical University, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University		Taichung			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7148977	Background	Goss DA. Attempts to reduce the rate of increase of myopia in young people--a critical literature review. Am J Optom Physiol Opt. 1982 Oct;59(10):828-41. doi: 10.1097/00006324-198210000-00010.
15008558	Background	Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese schoolchildren: 1983 to 2000. Ann Acad Med Singap. 2004 Jan;33(1):27-33.

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

ID	Term
D001286	Atropine Derivatives
D014326	Tropanes
D053961	Azabicyclo Compounds
D001372	Aza Compounds

Name	Type	Description	Arm Group Labels	Other Names
0.25 % atropine	Drug
0.5 % atropine	Drug
0.25 % atropine+auricular acupoints	Procedure