Toric Contact Lens Digital Performance and Comfort Study

NCT04772560 | Completed Results FDA Device

• 1 other identifier: STUDY00002753
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Toric, Then Sphere

EXPERIMENTAL

Participants who received Toric contact lenses first and spherical lenses after 10 days

Device: Precision1 for Astigmatism; Device: Precision1 Sphere

Sphere, Then Toric

EXPERIMENTAL

Participants who received Spherical contact lenses first and Toric lenses after 10 days

Device: Precision1 for Astigmatism; Device: Precision1 Sphere

Interventions

Precision1 for Astigmatism DEVICE

Daily disposable soft toric contact lens

Sphere, Then Toric; Toric, Then Sphere

Precision1 Sphere DEVICE

Daily disposable soft spherical contact lens

Sphere, Then Toric; Toric, Then Sphere

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• Kathryn Richdale: lead

Study Sites (1)

University of Houston College of Optometry

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Kathryn Richdale OD, PhD
• Organization: University of Houston

richdale@uh.edu

713-743-1974

Study Officials

• Kathryn Richdale

  University of Houston College of Optometry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: March 16, 2021
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: March 10, 2022
• Results First Posted: March 10, 2022

Record last verified: 2022-02

Locations

US (1)