Evaluating Contact Lens Optics

Myopia Clinical Trial

Official title:

Evaluating Contact Lens Optics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05028790
• Other study ID #: STUDY00002545
• Status: Completed
• Phase: N/A
• Start date: February 27, 2022
• Est. completion date: December 13, 2022

Study information

• Verified date: February 2024
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 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 -6.00D 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

• Unwilling to have contact lens fit photographed

• Pregnant and/or lactating females, by self-report

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Single vision contact lens
Participants will wear a single vision soft contact lens during the study visit
• Multifocal contact lens
Participants will wear a multifocal soft contact lens 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 acuity was measured for each participant while wearing each of the two lenses	Through completion of study visit, an average of 2.5 hours
Secondary	Spherical Equivalent Refractive Error On-axis	Refraction was measured after cycloplegia with two drops of 1% tropicamide hydrochloride. Spherical equivalent refractive error was then measured 3 times with an aberrometer and averaged.	Through completion of study visit, an average of 2.5 hours
Secondary	Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.	Through completion of study visit, an average of 2.5 hours
Secondary	Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.	Through completion of study visit, an average of 2.5 hours
Secondary	Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.	Through completion of study visit, an average of 2.5 hours
Secondary	Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina	Cycloplegic spherical equivalent refractive error was measured 3 times with an aberrometer and averaged.	Through completion of study visit, an average of 2.5 hours