Myopia Control With Simultaneous Vision Approach

July 2, 2014 updated by: Carly Lam, The Hong Kong Polytechnic University

Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach

To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. It comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Optometry Clinic, School of Optometry, The Hong Kong PolyU

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

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 8-13 years
  • Myopia (SE) between -1D to -5D
  • Astigmatism less than or equal to -1D
  • Anisometropia: less than or equal to 1.25D
  • aided VA (monocular): 0.00 log MAR or better
  • willingness to wear contact lens constantly
  • availability for follow-up for at least 2.5 years
  • parents' understanding and acceptance
  • willing to provide refractive status of grandparents

Exclusion Criteria:

  • Severe ocular or systemic allergies
  • Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
  • Ocular or systemic condition that might affect refractive development
  • Strabismus at distance or near
  • Prior use of bifocal or progressive lenses
  • Prior use of rigid gas permeable lenses and Ortho-K lenses

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: single vision soft contact lens
Single vision soft contact lenses with same materials of the DISC lens
Experimental: Defocus Incorporated Soft Contact (DISC) lens
The use of DISC lens to slow down the progression of myopia
Device: Defocus Incorporated Soft Contact (DISC) lens
Use of simultaneous vision bifocal soft contact lenses with myopic defocus to control the progression of myopia
Other Names:
  • myopia control
  • myopia progression
  • Simultaneous vision
  • bifocal contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of cycloplegic refractive errors
Time Frame: every 6 months for 2 years
Refractive error was measured using Shin-Nippon NVision-K 5001 autorefractor The changes of cycloplegic objective refractive errors between the treatment and the control were compared.
every 6 months for 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of axial length
Time Frame: every 6 months for 2 years
Axial length was measured after cycloplegia using IOL Master
every 6 months for 2 years

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Carly SY Lam, PhD, School of Optometry, The Hong Kong PolyU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Estimate)

July 3, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRF5438/06M

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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