Myopia Control Using Optimized Optical Defocus RCTs

August 22, 2022 updated by: Carly Lam, The Hong Kong Polytechnic University

Myopia Control Using Optimized Optical Defocus in Schoolchildren - a Randomized Double Masked Control Trial

The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.

The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.

The efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. The hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than spherical single vision soft contact lenses.

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

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
        • The Centre of Myopia Ressearch, 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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age at enrolment: 8-13 year; Hong Kong Chinese
  • Spherical equivalent refractions (SER): -1.00 to -5.00D
  • Astigmatism: -1.00D or less
  • Anisometropia: 1.25D or less
  • Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better
  • Contact lens corrected monocular VA: 0.1 logMAR or better
  • Normal binocular function
  • Willingness to wear contact lenses regularly
  • Parents' understanding and acceptance of random allocation of grouping and masking

Exclusion Criteria:

  • Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
  • Strabismus or decompensated phoria (checked by cover test at far and near in screening)
  • Known contraindications for contact lens wear
  • Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development

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, spherical soft contact lens
Experimental: DISC3.5 Plus lens
A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
Device: DISC3.5 plus
The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cycloplegic Refraction Change in SER
Time Frame: 12 months
Change in cycloplegic autorefraction in spherical equivalent (SER)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axial length
Time Frame: 12 months
Axial length (mm) was measured after cycloplegia
12 months

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 Polytechnic 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 (Actual)

October 25, 2018

Primary Completion (Actual)

May 8, 2021

Study Completion (Actual)

June 24, 2022

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 20, 2018

First Posted (Actual)

September 24, 2018

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20180711001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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