Toric Contact Lens Digital Performance and Comfort Study

Kathryn Richdale30 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Astigmatism

Interventions

Precision1 for AstigmatismDEVICE

Daily disposable soft toric contact lens

Precision1 SphereDEVICE

Daily disposable soft spherical contact lens

Eligibility

Sex: ALLMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Houston College of Optometry

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 10 +/- 2 days

Data from ClinicalTrials.gov

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