Contact Lens Optics and Visual Performance

• Sponsor: David A Berntsen, OD PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT05308069
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.4
• Patients Per Site Per Month: 16.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Single vision contact lens; Device: Multifocal contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Contact Lens Optics and Visual Performance
• Actual Study Start Date: Jun 13, 2022
• Actual Primary Completion Date: Jul 27, 2022
• Actual Study Completion Date: Jul 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Single vision contact lens Subjects will wear a single vision soft contact lens during the study visit	Device: Single vision contact lens; Subjects will wear a single vision soft contact lens only during the study visit; Other Names: comfilcon A
Other: Multifocal contact lens Subjects will wear a multifocal soft contact lens during the study visit	Device: Multifocal contact lens; Subjects will wear a multifocal soft contact lens only during the study visit; Other Names: comfilcon A

Outcome Measures

Primary Outcome Measures

1. Visual performance [Through completion of study visit, an average of 3 hours]

   Low contrast visual performance will be measured at different pupil sizes for each subject while wearing each of the two lenses

Secondary Outcome Measures

1. Refractive error [Through completion of study visit, an average of 3 hours]

   Refractive error will be measured with an autorefractor and an aberrometer with subjects wearing each of the two lenses

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Houston	Houston	Texas	United States	77204

Sponsors and Collaborators

• David A Berntsen, OD PhD

Investigators

• Principal Investigator: David A Berntsen, OD, PhD, University of Houston College of Optometry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David A Berntsen, OD PhD, Associate Professor, University of Houston
• ClinicalTrials.gov Identifier: NCT05308069
• Other Study ID Numbers: STUDY00003513
• First Posted: Apr 1, 2022
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Aug 9, 2022