Myopia Control Using Soft Bifocal Lenses

February 21, 2019 updated by: Pauline Cho, The Hong Kong Polytechnic University

Randomised Clinical Trial: Myopia Control Using Soft Bifocal Lenses

The purpose of this study is to evaluate whether bifocal soft contact lenses (CLs) with low addition and nasally decentered optical zone are effective in controlling myopic progression in children. Visual manipulations induced by multifocal soft CLs with high addition have been shown to inhibit eye growth and myopia development in children by recent studies. Several theories have been proposed including alteration in peripheral defocus, reduced accommodation demand, alterations in binocular vision status and increased ocular higher order aberrations. However, those theories remain to be proven and the optical properties and performance of multifocal soft CLs have not been investigated in children.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Visual manipulations induced by multifocal soft contact lenses (CLs) with high addition (+2.00 D or above) have been shown to inhibit eye growth and myopia development in children with up to 25-50% efficacy by recent studies. Several theories have been proposed including; alteration in peripheral defocus, reduced accommodation demand, alterations in binocular vision status and increased ocular higher order aberrations, which remain to be proven. However, the effect of controlling myopic progression by bifocal CLs with low addition has not been studied.

Several studies have shown that multifocal soft CLs can induce changes in ocular aberrations and degradation of image qualities in adults, whereas the optical properties and performance of multifocal soft CLs have not been investigated in children. Due to the differences in ocular structure and function, for instance, the pupil size and accommodation response, the performance of multifocal CLs in children may vary compared with that in adults. As a result, it is essential to assess the optical quality of these lenses worn by children for myopia control, through COAS (Complete Ophthalmic Analysis System).

The aim of this randomized clinical trial is to evaluate myopic progression in children wearing soft bifocal with low addition CLs (Menicon 2 week Duo **) used as daily disposable lenses, compared to control subjects wearing single-vision spectacles. Myopia progression quantified by changes in axial length (AL) and cycloplegic refractive error (Rx) will be monitored for 2 years with single-masking. The optical performance of bifocal CLs worn by children will also be investigated.

(**this lens is currently commercially available in Japan only. The oxygen permeability (Dk) is 34 with 72% water content, FDA group Ⅱ.)

Study Type

Interventional

Enrollment (Actual)

97

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

  • Hong Kong
      • Kowloon, Hong Kong
        • School of Optometry, The Hong Kong Polytechnic University

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

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Refractive sphere: -0.75 D to -4.50 D
  • Refractive cylinder: not exceed 1.00 D
  • Spherical equivalent: -0.75 D to -5.00 D
  • Best corrected distance VA (LogMAR): 0.14 or better in each eye and 0.10 or better in both eyes
  • Difference in refractive error (spherical equivalent) in the two eyes: not exceed 1.00 D

Exclusion Criteria:

  • Prior history of myopia control treatment
  • Contraindication to contact lens wear
  • Binocular anomalies (e.g. strabismus)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bifocal soft contact lenses
Device: Bifocal soft contact lenses Use of bifocal contact lenses with nasally decentered optical zone to control the progression of myopia
Device: Bifocal soft contact lenses
Other Names:
  • Menicon Duo 2 week soft bifocal lenses
No Intervention: Single vision spectacles
Control: Single vision spectacles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in axial length in 2 years
Time Frame: Every 6 months for a period of 2 years
Evaluate the changes in cycloplegic axial length in children wearing bifocal soft contact lenses with low addition used as daily disposable lenses compared to control subjects wearing single-vision spectacles for two years with single masking and randomisation
Every 6 months for a period of 2 years
Changes in cycloplegic refractive error in 2 years
Time Frame: Every 6 months for a period of 2 years
Evaluate the changes in cycloplegic refractive error in children wearing bifocal soft contact lenses with low addition used as daily disposable lenses compared to control subjects wearing single-vision spectacles for two years with single masking and randomisation
Every 6 months for a period of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in wavefront aberrations in 2 years
Time Frame: Every 6 months for a period of 2 years
Assess changes in aberration profile by COAS (Complete Ophthalmic Analysis System) over a period of 2 years
Every 6 months for a period of 2 years
Changes in accommodation responses in 2 years
Time Frame: Every 6 months for a period of 2 years
Assess changes in the accommodation responses of children over a period of two years
Every 6 months for a period of 2 years
Changes in wavefront aberrations of children with bifocal soft contact lenses in 2 years
Time Frame: Every 6 months for a period of 2 years
Assess the aberration profile of children wearing bifocal soft contact lenses by COAS (Complete Ophthalmic Analysis System) over a period of 2 years
Every 6 months for a period of 2 years

Collaborators and Investigators

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

Sponsor

The Hong Kong Polytechnic University

Collaborators

Queensland University of Technology
Menicon Co., Ltd.

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 (Actual)

January 25, 2016

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

December 31, 2015

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20151016008

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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