Customizing Myopia Control With Multifocal Toric Contact Lens

Overview

This study will evaluate the ability of toric multifocal contact lens to reduce the change of myopia progression in children (aged 8-12) with myopic astigmatism.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2021

Detailed Description

The purpose of this study is to assess if a center distance toric multifocal contact lenses can slow the amount of change of myopia progression in children with myopia plus astigmatism. Multifocal contact lenses have been theorized to influence the peripheral optics of the eye such that they slow the rate of myopia progression in nearsighted children. This outcome is yet to be evaluated in children with myopia plus astigmatism.The secondary outcome is to measure the change in peripheral optics caused by the contact lens. This information is key to understanding the mechanism of multifocal contact lens optics on the eye. Ultimately this information would be used to create a software that can estimate the effect of multifocal contact lenses on the peripheral optics of the child's eye. This software can potentially be used by practitioners worldwide to better customize multifocal contact lenses to slow myopia progression.

Interventions

  • Device: Intelliwave multifocal, toric, soft contact lens
    • This is a quarterly disposable, multifocal, toric soft contact lens commercially available from Art Optical Contact Lens, Inc.
  • Device: Intelliwave toric, soft contact lens
    • This is a quarterly disposable toric soft contact lens commercially available from Art Optical Contact Lens, Inc.

Arms, Groups and Cohorts

  • Active Comparator: Toric soft contact lens
    • Toric soft contact lens
  • Experimental: Multifocal toric soft contact lens
    • A multifocal toric soft contact lens with a +2.00 D add.

Clinical Trial Outcome Measures

Primary Measures

  • Refractive error progression
    • Time Frame: 1 years
    • Refractive error measured by cycloplegic autorefraction in both eyes, will be measured at baseline and at one year to assess the difference in spherical component of the refractive error between the treatment group (multifocal toric soft contact lens) and the control group (toric soft contact lens)
  • Axial length
    • Time Frame: 1 years
    • Change in axial length as measured by non-contact axial length both eyes, will be measured at baseline and at one year to assess the difference in change in axial length between the treatment group (multifocal toric soft contact lens) and the control group (toric soft contact lens)

Participating in This Clinical Trial

Inclusion Criteria

  • 8 to 12 years, inclusive, at baseline examination
  • -0.50 to -6.00 D, inclusive, spherical component, cycloplegic autorefraction
  • ≥0.75 DC, cycloplegic autorefraction
  • 0.1 logMAR or better best-corrected visual acuity in each eye

Exclusion Criteria

  • Eye disease or refractive error conditions (e.g., keratoconus, retinal abnormalities, retinopathy of prematurity, etc.)
  • Ocular surgery, severe ocular trauma, active ocular infection or inflammation
  • Subjects with a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrew Pucker, Assistant Professor – University of Alabama at Birmingham
  • Overall Official(s)
    • Andrew D Pucker, OD, PhD, Principal Investigator, University of Alabama at Birmingham
  • Overall Contact(s)
    • Andrew D Pucker, OD, PhD, 205.975.9938, apucker@uab.edu

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