Toric Contact Lens Digital Performance and Comfort Study
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Toric, Then Sphere Participants who received Toric contact lenses first and spherical lenses after 10 days |
Device: Precision1 for Astigmatism
Daily disposable soft toric contact lens
Device: Precision1 Sphere
Daily disposable soft spherical contact lens
|
Experimental: Sphere, Then Toric Participants who received Spherical contact lenses first and Toric lenses after 10 days |
Device: Precision1 for Astigmatism
Daily disposable soft toric contact lens
Device: Precision1 Sphere
Daily disposable soft spherical contact lens
|
Outcome Measures
Primary Outcome Measures
- Near Visual LogMAR Acuity [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 [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
Eligibility Criteria
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)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Houston College of Optometry | Houston | Texas | United States | 77204 |
Sponsors and Collaborators
- Kathryn Richdale
Investigators
- Principal Investigator: Kathryn Richdale, University of Houston College of Optometry
Study Documents (Full-Text)
More Information
Publications
None provided.- STUDY00002753
Study Results
Participant Flow
Recruitment Details | 30 participants were screened for eligibility between March and December 2021 |
---|---|
Pre-assignment Detail | 23 of 30 participants were randomized. Of those not randomized, 7 did not meet inclusion criteria. |
Arm/Group Title | Toric Then Spherical | Spherical Then Toric |
---|---|---|
Arm/Group Description | Participants who received toric contact lenses first and spherical lenses after 10 days | Participants who received spherical contact lenses first and toric lenses after 10 days |
Period Title: Overall Study | ||
STARTED | 11 | 12 |
COMPLETED | 11 | 12 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | 23 participants who had completed the study |
Overall Participants | 23 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
24.4
(4.2)
|
Sex: Female, Male (Count of Participants) | |
Female |
17
73.9%
|
Male |
6
26.1%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
9
39.1%
|
Not Hispanic or Latino |
14
60.9%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
1
4.3%
|
Asian |
8
34.8%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
3
13%
|
White |
11
47.8%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (participants) [Number] | |
United States |
23
100%
|
Outcome Measures
Title | Near Visual LogMAR Acuity |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | 23 participants who had completed the study |
Measure Participants | 23 |
Toric CL |
-0.10
(0.02)
|
Spherical CL |
-0.03
(0.21)
|
Title | Dynamic Visual Acuity |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | All Participants |
---|---|
Arm/Group Description | 23 participants who had completed the study |
Measure Participants | 23 |
Toric CL |
0.04
(0.02)
|
Spherical CL |
0.11
(0.02)
|
Adverse Events
Time Frame | 10 ± 2 days for each intervention | |||
---|---|---|---|---|
Adverse Event Reporting Description | AE information was collected at each study visit | |||
Arm/Group Title | Toric Contact Lens Wear | Spherical Contact Lens Wear | ||
Arm/Group Description | 23 participants had completed the study | 23 participants had completed the study | ||
All Cause Mortality |
||||
Toric Contact Lens Wear | Spherical Contact Lens Wear | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/23 (0%) | 0/23 (0%) | ||
Serious Adverse Events |
||||
Toric Contact Lens Wear | Spherical Contact Lens Wear | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/23 (0%) | 0/23 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Toric Contact Lens Wear | Spherical Contact Lens Wear | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/23 (17.4%) | 0/23 (0%) | ||
Eye disorders | ||||
Corneal staining | 3/23 (13%) | 3 | 0/23 (0%) | 0 |
Hordeolum | 1/23 (4.3%) | 1 | 0/23 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Kathryn Richdale OD, PhD |
---|---|
Organization | University of Houston |
Phone | 713-743-1974 |
richdale@uh.edu |
- STUDY00002753