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Evaluating Contact Lens Optics

D

David A Berntsen, OD PhD

Status

Completed

Conditions

Myopia

Treatments

Device: Multifocal contact lens
Device: Single vision contact lens

Study type

Interventional

Funder types

Other

Identifiers

NCT05028790
STUDY00002545

Details and patient eligibility

About

This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens

Enrollment

16 patients

Sex

All

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Able to read and understand the informed consent document
  • 18 to 39 years of age (inclusive)
  • Best corrected visual acuity of 20/25 or better in the right eye
  • Refractive error from -1.00D to -6.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)

Exclusion criteria

  • Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens
  • History of ocular trauma or surgery causing abnormal or distorted vision
  • Current Rigid Gas Permeable (RGP) contact lens wearers
  • Unwilling to have contact lens fit photographed
  • Pregnant and/or lactating females, by self-report

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

16 participants in 2 patient groups

Single vision soft contact lens first, then multifocal soft contact lens
Experimental group
Description:
Participants wore the single vision soft contact lens first, then a multifocal soft contact lens
Treatment:
Device: Multifocal contact lens
Device: Single vision contact lens
Multifocal soft contact lens first, then single vision soft contact lens
Experimental group
Description:
Participants wore the multifocal soft contact lens first, then the single vision soft contact lens
Treatment:
Device: Multifocal contact lens
Device: Single vision contact lens

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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