Trial of Myopia Prevention Using +3D Lenses | NCT00627874

Studies
Trial of Myopia Prevention Using +3D Lenses

NCT00627874

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Feb 24, 2009Estimated

Enrollment

1,200Estimated

Phase

Not Applicable

Conditions

Myopia

Interventions

+3D Lenses

Countries

Not provided

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Apr 2012Estimated

Completion Date

Apr 2012Estimated

First Submitted Date

Feb 20, 2008

First Submission Date that Met QC Criteria

Feb 24, 2008

First Posted Date

Mar 4, 2008Estimated

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

Feb 20, 2009

Last Update Posted Date

Feb 24, 2009Estimated

Name	Class
Australian National University	OTHER

Description Module

Brief Summary

The purpose of this study is to assess whether a short-term imposed myopic defocus is effective in preventing the development and progression of juvenile-onset myopia in Chinese children.

Detailed Description

To determine if +3D lenses wearing for half an hour everyday prevents the development and progression of myopia in school children.
To identify ocular parameters and risk factors at baseline associated with development and progression of myopia.

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

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m	Device: +3D Lenses
2	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
+3D Lenses	Device	wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m	1

Measure	Description	Time Frame
Axial Length of eyes		Annual

Measure	Description	Time Frame
Autorefraction		Annual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All children in the selected class are enrolled

Exclusion Criteria:

Hyperopia > +2.0 D
High myopia > -6.0 D
Astigmatism> 1.5 D
Anisometropia > 1.5 D
Strabismus and amblyopia
Any ocular, systemic, or neurodevelopmental conditions that could influence refractive development
Chronic medication use that might affect myopia progression or visual acuity
Already receiving other treatment for progressing myopia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mingguang He, PhD, MD	Zhongshan Ophthalmic Center, Sun Yat-sen University	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided