Customizing Myopia Control With Multifocal Toric Contact Lens

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04352868

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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

Anticipated Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Refractive error progression [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.