Toric Contact Lens Digital Performance and Comfort Study

Astigmatism Clinical Trial

Official title:

Toric Contact Lens Digital Performance and Comfort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772560
• Other study ID #: STUDY00002753
• Status: Completed
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: December 13, 2021

Study information

• Verified date: February 2022
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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)

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• Precision1 for Astigmatism
Daily disposable soft toric contact lens
• Precision1 Sphere
Daily disposable soft spherical contact lens

Locations

Country	Name	City	State
United States	University of Houston College of Optometry	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kathryn Richdale

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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