Toric Contact Lens Digital Performance and Comfort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Near Visual LogMAR Acuity
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Exclusion Criteria
- Not provided
Arms & Interventions
Toric, Then Sphere
Participants who received Toric contact lenses first and spherical lenses after 10 days
Intervention: Precision1 for Astigmatism (Device)
Toric, Then Sphere
Participants who received Toric contact lenses first and spherical lenses after 10 days
Intervention: Precision1 Sphere (Device)
Sphere, Then Toric
Participants who received Spherical contact lenses first and Toric lenses after 10 days
Intervention: Precision1 for Astigmatism (Device)
Sphere, Then Toric
Participants who received Spherical contact lenses first and Toric lenses after 10 days
Intervention: Precision1 Sphere (Device)
Outcomes
Primary Outcomes
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.
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Kathryn Richdale
Associate professor
University of Houston