Toric Contact Lens Digital Performance and Comfort Study

Kathryn Richdale

Status: Completed

Conditions: Astigmatism

Treatments: Device: Precision1 Sphere; Device: Precision1 for Astigmatism

Study type: Interventional

Funder types: Other

Identifiers

NCT04772560

STUDY00002753

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Toric, Then Sphere

Experimental group

Description:

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

Treatment:

Device: Precision1 Sphere

Device: Precision1 for Astigmatism

Sphere, Then Toric

Experimental group

Description:

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

Treatment:

Device: Precision1 Sphere

Device: Precision1 for Astigmatism