Evaluating Contact Lens Optics

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Single vision contact lens; Device: Multifocal contact lens

• Registration Number: NCT05028790
• Lead Sponsor: David A Berntsen, OD PhD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-31
• Study Start: 2022-02-27
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13
• Results First Submitted: 2023-11-28
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Results First Posted: 2024-02-06
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single vision soft contact lens first, then multifocal soft contact lens	Single vision contact lens	Participants wore the single vision soft contact lens first, then a multifocal soft contact lens
Multifocal soft contact lens first, then single vision soft contact lens	Single vision contact lens	Participants wore the multifocal soft contact lens first, then the single vision soft contact lens
Multifocal soft contact lens first, then single vision soft contact lens	Multifocal contact lens	Participants wore the multifocal soft contact lens first, then the single vision soft contact lens
Single vision soft contact lens first, then multifocal soft contact lens	Multifocal contact lens	Participants wore the single vision soft contact lens first, then a multifocal soft contact lens

Primary Outcome Measures

Name	Time	Method
Visual Performance	Through completion of study visit, an average of 2.5 hours	Low contrast visual acuity was measured for each participant while wearing each of the two lenses

Secondary Outcome Measures

Name	Time	Method
Spherical Equivalent Refractive Error On-axis	Through completion of study visit, an average of 2.5 hours	Refraction was measured after cycloplegia with two drops of 1% tropicamide hydrochloride. Spherical equivalent refractive error was then measured 3 times with an aberrometer and averaged.
Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina	Through completion of study visit, an average of 2.5 hours	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina	Through completion of study visit, an average of 2.5 hours	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina	Through completion of study visit, an average of 2.5 hours	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.
Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina	Through completion of study visit, an average of 2.5 hours	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.

Trial Locations

Locations (1)

University of Houston; 🇺🇸 Houston, Texas, United States