Contact Lens Optics and Visual Performance
1 other identifier
interventional
24
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2022
CompletedFirst Posted
Study publicly available on registry
April 1, 2022
CompletedStudy Start
First participant enrolled
June 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2022
CompletedAugust 9, 2022
August 1, 2022
1 month
March 24, 2022
August 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Visual performance
Low contrast visual performance will be measured at different pupil sizes for each subject while wearing each of the two lenses
Through completion of study visit, an average of 3 hours
Secondary Outcomes (1)
Refractive error
Through completion of study visit, an average of 3 hours
Study Arms (2)
Single vision contact lens
OTHERSubjects will wear a single vision soft contact lens during the study visit
Multifocal contact lens
OTHERSubjects will wear a multifocal soft contact lens during the study visit
Interventions
Subjects will wear a single vision soft contact lens only during the study visit
Subjects will wear a multifocal soft contact lens only during the study visit
Eligibility Criteria
You may qualify if:
- Able to read and understand the informed consent document
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Houston
Houston, Texas, 77204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Berntsen, OD, PhD
University of Houston College of Optometry
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 24, 2022
First Posted
April 1, 2022
Study Start
June 13, 2022
Primary Completion
July 27, 2022
Study Completion
July 27, 2022
Last Updated
August 9, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share