Customizing Myopia Control With Multifocal Toric Contact Lens

Myopia Clinical Trial

Official title:

Customizing Myopia Control With Multifocal Toric Contact Lens

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04352868
• Other study ID #: IRB-300004596
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

Intervention

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.
• Intelliwave toric, soft contact lens
This is a quarterly disposable toric soft contact lens commercially available from Art Optical Contact Lens, Inc.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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