Contact Lens Optics and Visual Performance

Myopia Clinical Trial

Official title:

Contact Lens Optics and Visual Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05308069
• Other study ID #: STUDY00003513
• Status: Completed
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: July 27, 2022

Study information

• Verified date: August 2022
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Single vision contact lens
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 only during the study visit

Locations

Country	Name	City	State
United States	University of Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
David A Berntsen, OD PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Refractive error	Refractive error will be measured with an autorefractor and an aberrometer with subjects wearing each of the two lenses	Through completion of study visit, an average of 3 hours