Toric Contact Lens Digital Performance and Comfort Study

This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Precision1 for Astigmatism; Device: Precision1 Sphere

Detailed Description

This study seeks to quantify the near visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients. Primary Hypotheses: Subjects will have better near visual acuity and near visual performance with toric, as opposed to spherical, contact lens correction. As such, the following hypotheses will be tested: H01: There is no statistically significant difference in near visual acuity or near vision performance between contact lenses corrections Ha1: There is a statistically significant difference in visual acuity or vision performance between contact lenses corrections

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • University of Houston College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 to 39 years of age (inclusive)
• pl to -6.00D vertexed sphere power and -0.75 to -1.50D vertexed refractive cylinder OD and OS
• Current/established full time (>6 days week, >8 hours/day) soft contact lens wearer
• Best corrected acuity of 20/25 or better in each eye
• Self-report of at least 4 hrs/day using digital devices
• Willing to wear lenses at least 8 hours each day during the study period
• Able to speak and read English at a high school level / have at least a high school diploma or equivalent (by self-report)

Enclusion Criteria:

• History of ocular pathology or surgery
• Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency)
• Gas permeable lens wear for at least 3 months
• Symptomatic soft contact lens wearer (CLDEQ-8 score <12 at baseline)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Toric, Then Sphere; Participants who received Toric contact lenses first and spherical lenses after 10 days	Device: Precision1 for Astigmatism; Daily disposable soft toric contact lens; Device: Precision1 Sphere; Daily disposable soft spherical contact lens
Experimental: Sphere, Then Toric; Participants who received Spherical contact lenses first and Toric lenses after 10 days	Device: Precision1 for Astigmatism; Daily disposable soft toric contact lens; Device: Precision1 Sphere; Daily disposable soft spherical contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near Visual LogMAR Acuity	High contrast LogMAR visual acuity was assessed at 40 cm using the M&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly 10+/-2 days after each intervention. The test started at 20/60 and continued until three letters were missed on a line.	10 +/- 2 days
Dynamic Visual Acuity	Dynamic VA was determined using a custom-made iPad application. The subject was instructed to hold the iPad at 40cm and presented with a Landolt C surrounded by crowding bars for 0.3s each, starting from 0.5 LogMAR and progressing to smaller sizes using a staircase threshold method. Testing was performed binocularly 10+/-2 days after each intervention	10 +/- 2 days

Collaborators and Investigators

• Sponsor: Kathryn Richdale
• Investigators: Principal Investigator: Kathryn Richdale, University of Houston College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): December 13, 2021
• Study Completion (Actual): December 13, 2021

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: STUDY00002753

Drug and device information, study documents

• 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.: Yes