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Customizing Myopia Control With Multifocal Toric Contact Lens

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ClinicalTrials.gov Identifier: NCT04352868
Recruitment Status : Withdrawn (COVID-19)
First Posted : April 20, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew Pucker, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Refractive Errors Myopia Device: Intelliwave multifocal, toric, soft contact lens Device: Intelliwave toric, soft contact lens Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Customizing Myopia Control With Multifocal Toric Contact Lens
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Toric soft contact lens
Toric soft contact lens
Device: Intelliwave toric, soft contact lens
This is a quarterly disposable toric soft contact lens commercially available from Art Optical Contact Lens, Inc.

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




Primary Outcome Measures :
  1. 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)

  2. 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)



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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352868


Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Andrew D Pucker, OD, PhD University of Alabama at Birmingham
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Responsible Party: Andrew Pucker, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04352868    
Other Study ID Numbers: IRB-300004596
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual subject data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Andrew Pucker, University of Alabama at Birmingham:
Myopia
Multifocal contact lens
Refractive error
Myopia treatment
Myopia control
Myopia management
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases