Trial of Myopia Prevention Using +3D Lenses (PLS)

February 20, 2009 updated by: Sun Yat-sen University

A Randomised, Controlled Trial of Prevention of Juvenile-Onset Myopia in Chinese Children

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  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.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Experimental: 1
wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m
Device: +3D Lenses
wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Axial Length of eyes
Time Frame: Annual
Annual

Secondary Outcome Measures

Outcome Measure
Time Frame
Autorefraction
Time Frame: Annual
Annual

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Australian National University

Investigators

  • Study Director: Mingguang He, PhD, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 24, 2008

First Posted (Estimate)

March 4, 2008

Study Record Updates

Last Update Posted (Estimate)

February 24, 2009

Last Update Submitted That Met QC Criteria

February 20, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLS2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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