Astigmatism
Conditions
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
Interventions
Daily disposable soft toric contact lens
DEVICEPrecision1 Sphere
Daily disposable soft spherical contact lens
Sponsors
Kathryn Richdale
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
30 participants were screened for eligibility between March and December 2021
Pre-assignment details
23 of 30 participants were randomized. Of those not randomized, 7 did not meet inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| All Participants 23 participants who had completed the study | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 24.4 years STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 4 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
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
Time frame: 10 +/- 2 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Dynamic Visual Acuity | Toric CL | 0.04 LogMAR | Standard Error 0.02 |
| All Participants | Dynamic Visual Acuity | Spherical CL | 0.11 LogMAR | Standard Error 0.02 |
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.
Time frame: 10 +/- 2 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Near Visual LogMAR Acuity | Toric CL | -0.10 LogMAR | Standard Error 0.02 |
| All Participants | Near Visual LogMAR Acuity | Spherical CL | -0.03 LogMAR | Standard Error 0.21 |