Clinical Trial: Myopia Control Using Soft Bifocal Lenses

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Randomised Clinical Trial: Myopia Control Using Soft Bifocal Lenses

Brief Summary: 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.

Detailed Summary:

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.)


Sponsor: The Hong Kong Polytechnic University

Current Primary Outcome:

  • 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
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: The Hong Kong Polytechnic University

Dates:
Date Received: December 8, 2015
Date Started: November 2015
Date Completion: March 2019
Last Updated: August 19, 2016
Last Verified: August 2016