Customizing Myopia Control With Multifocal Toric Contact Lens

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 Overview

• Status: Withdrawn
• Conditions: Refractive Errors; Myopia
• Intervention / Treatment: Device: Intelliwave toric, soft contact lens; Device: Intelliwave multifocal, toric, soft contact lens

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refractive error progression	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)	1 years
Axial length	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)	1 years

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Myopia; Refractive error; Myopia control; Myopia treatment; Multifocal contact lens; Myopia management
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: IRB-300004596

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual subject data.

Drug and device information, study documents

• 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