Trial of Myopia Prevention Using +3D Lenses

NCT ID: NCT00627874

Last Updated: 2009-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-04-30

Brief Summary

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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

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

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m

Group Type EXPERIMENTAL

+3D Lenses

Intervention Type DEVICE

wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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+3D Lenses

wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Australian National University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhongshan Ophthalmic Center, ZOC

Principal Investigators

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Mingguang He, PhD, MD

Role: STUDY_DIRECTOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other Identifiers

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PLS2008

Identifier Type: -

Identifier Source: org_study_id

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