NCT04352868

Customizing Myopia Control With Multifocal Toric Contact Lens

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractive Errors
• Myopia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-09-01
• Completion: 2022-09-01
• First posted: 2020-04-20
• Last updated: 2020-11-09

Regulatory

• FDA-regulated device study