Toric Contact Lens Digital Performance and Comfort Study

• ClinicalTrials.gov Identifier: NCT04772560
• Recruitment Status: Completed
• First Posted: February 26, 2021
• Results First Posted: March 10, 2022
• Last Update Posted: March 10, 2022
• Sponsor: Kathryn Richdale
• Information provided by (Responsible Party): Kathryn Richdale, University of Houston

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Astigmatism	Device: Precision1 for Astigmatism; Device: Precision1 Sphere	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Toric Contact Lens Digital Performance and Comfort Study
• Actual Study Start Date: March 16, 2021
• Actual Primary Completion Date: December 13, 2021
• Actual Study Completion Date: December 13, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Near Visual LogMAR Acuity [ Time Frame: 10 +/- 2 days ]
   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.
2. Dynamic Visual Acuity [ Time Frame: 10 +/- 2 days ]
   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

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United States, Texas

University of Houston College of Optometry

Houston, Texas, United States, 77204

Sponsors and Collaborators

Kathryn Richdale

Investigators

• Principal Investigator: Kathryn Richdale; University of Houston College of Optometry

  Study Documents (Full-Text)

Documents provided by Kathryn Richdale, University of Houston:

Study Protocol and Informed Consent Form  [PDF] August 18, 2021

Statistical Analysis Plan  [PDF] December 20, 2021

More Information

• Responsible Party: Kathryn Richdale, Associate professor, University of Houston
• ClinicalTrials.gov Identifier: NCT04772560
• Other Study ID Numbers: STUDY00002753
• First Posted: February 26, 2021
• Results First Posted: March 10, 2022
• Last Update Posted: March 10, 2022
• Last Verified: February 2022

• 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

Additional relevant MeSH terms:

Astigmatism; Refractive Errors; Eye Diseases