- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07840209
Comparison of Hand Eye Coordination and Sports Vision Performance in Dual-Focus Multifocal Contact Lenses and Habitual Contact Lenses
The purpose of the study is to compare the hand-eye coordination and sports vision performance in participants while they are wearing their habitual contact lenses versus while wearing the dual-focus multifocal contact lenses.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: iVERG Reserch Group
- Phone Number: 614-292-8858
- Email: OPT-EyeStudies@osu.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- College of Optometry
-
Contact:
- iVERG Research Group
- Phone Number: 614-292-8858
- Email: OPT-EyeStudies@osu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult, aged 18 to 38 with baseball or softball playing experience (high school or higher in the last 10 years)
- Ability to give informed consent
- Good general health defined by medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator
- Current myopic spherical soft contact lens wearer with a prescription equivalent to the multifocal lens powers available
- Visual acuity of 20/25 or better in each eye with current soft contact lenses
- Visual acuity of 20/25 or better in each eye in multifocal contact lenses
- Stereoacuity of 40" or better at 40 cm
- Willing to spend time required for attending 3 study visits and wearing contact lenses on days between study visits
- Any gender
- Any racial or ethnic origin
Exclusion Criteria:
- Current or active inflammation, infection, or eye disease as determined by the Investigator
- A systemic condition that in the opinion of the investigator may affect a study outcome
- Strabismus
- Unable to successfully wear the MiSight contact lenses for the duration of the study
- Females who are pregnant, lactating, or planning to conceive during the study
- Use of systemic or topical medication that in the opinion of the investigator may affect a study outcome variable
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Habitual contact lenses worn first, multifocal lenses worn second
Participants will wear their habitual contact lenses while completing tasks first, then wear the provided multifocal lenses while completing tasks again. |
Multifocal Contact Lens |
|
Experimental: Multifocal lenses worn first, habitual lenses worn second.
Participants will wear the multifocal lenses while completing tasks first, then wear their habitual lenses while completing tasks again. |
Multifocal Contact Lens |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand-eye coordination and sport vision performance
Time Frame: 3 weeks
|
The average score of the AcuVision while wearing the multifocal contact lenses compared to the score when wearing their habitual contact lenses. |
3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20261434
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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