Low Concentration Atropine for Myopia Progression in Scho... | NCT02130167

Studies
Low Concentration Atropine for Myopia Progression in School Children

NCT02130167

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Jan 30, 2018Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Myopia Progression

Interventions

Atropine

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

Jan 2018

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

Aug 2012

Primary Completion Date

Jul 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Apr 28, 2014

First Submission Date that Met QC Criteria

May 1, 2014

First Posted Date

May 5, 2014Estimated

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

Jan 29, 2018

Last Update Posted Date

Jan 30, 2018Actual

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

Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Recently the 0.01% atropine was also reported effective and with less visual side effects such as mydriasis. The aim of this study is to compare the efficacy in controlling myopia progression and visual side effects of 2 low concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.01% Atropine	Experimental		Drug: Atropine
0.05% Atropine	Active Comparator		Drug: Atropine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atropine	Drug	Compare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine	0.01% Atropine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cycloplegic spherical refraction change	Cycloplegic spherical refraction change is the main indicator of the myopia progression.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Axial length change	Axial length change is another indicator of the myopia progression.Using non-contact biometry. unit: millimeter(mm)	1 year

Other Outcomes

Measure	Description	Time Frame
pupil size	Using computer scaling software. unit: millimeter(mm)	6 months
accommodation	Using accommodometer to measuer accommodation. Unit: diopeter

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.

Exclusion Criteria:

strabismus, amblyopia. cataract, glaucoma or any ocular diseases ocular surgery history systemic diseases (ex. asthma, heart disease...)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pei-Chang Wu, MD,PhD	Dep. of Ophthalmology, Kaohsiung Chang Gung Memorial Hospital, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Chang Gung Memorial Hospital		Kaohsiung City		833	Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D001285	Atropine

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided