Customizing Myopia Control With Multifocal Toric Contact Lens

Not Applicable

Withdrawn

• Conditions: Myopia; Refractive Errors
• Interventions: Device: Intelliwave toric, soft contact lens; Device: Intelliwave multifocal, toric, soft contact lens

• Registration Number: NCT04352868
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-20
• Study Start: 2020-09-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-09
• Primary Completion: 2021-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toric soft contact lens	Intelliwave toric, soft contact lens	Toric soft contact lens
Multifocal toric soft contact lens	Intelliwave multifocal, toric, soft contact lens	A multifocal toric soft contact lens with a +2.00 D add.

Primary Outcome Measures

Name	Time	Method
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)