Contact Lens Optics and Visual Performance

NCT ID: NCT05308069

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2022-07-27

Brief Summary

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This study will evaluate changes in visual performance at different pupil sizes between a single vision soft contact lens and multifocal soft contact lens, and compare refractive error measured between these two lenses with an autorefractor and an aberrometer

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Single vision contact lens

Subjects will wear a single vision soft contact lens during the study visit

Group Type OTHER

Single vision contact lens

Intervention Type DEVICE

Subjects will wear a single vision soft contact lens only during the study visit

Multifocal contact lens

Subjects will wear a multifocal soft contact lens during the study visit

Group Type OTHER

Multifocal contact lens

Intervention Type DEVICE

Subjects will wear a multifocal soft contact lens only during the study visit

Interventions

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Single vision contact lens

Subjects will wear a single vision soft contact lens only during the study visit

Intervention Type DEVICE

Multifocal contact lens

Subjects will wear a multifocal soft contact lens only during the study visit

Intervention Type DEVICE

Other Intervention Names

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comfilcon A comfilcon A

Eligibility Criteria

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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 -8.00D 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
* Pregnant and/or lactating females, by self-report
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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David A Berntsen, OD PhD

OTHER

Sponsor Role lead

Responsible Party

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David A Berntsen, OD PhD

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David A Berntsen, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Houston College of Optometry

Locations

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University of Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00003513

Identifier Type: -

Identifier Source: org_study_id

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