Customizing Myopia Control With Multifocal Toric Contact Lens

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Withdrawn

Conditions

Myopia
Refractive Errors

Treatments

Device: Intelliwave toric, soft contact lens
Device: Intelliwave multifocal, toric, soft contact lens

Study type

Interventional

Funder types

Other

Identifiers

NCT04352868
IRB-300004596

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

8 to 12 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups

Toric soft contact lens
Active Comparator group
Description:
Toric soft contact lens
Treatment:
Device: Intelliwave toric, soft contact lens
Multifocal toric soft contact lens
Experimental group
Description:
A multifocal toric soft contact lens with a +2.00 D add.
Treatment:
Device: Intelliwave multifocal, toric, soft contact lens

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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