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OpenTrials
Completed

NCT Number: NCT04772560

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Houston College of Optometry

Houston, Texas, 77204, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Precision1 for Astigmatism

Device

Daily disposable soft toric contact lens

Precision1 Sphere

Device

Daily disposable soft spherical contact lens

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kathryn Richdale

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 26, 2021
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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