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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toric, Then Sphere | Experimental | Participants who received Toric contact lenses first and spherical lenses after 10 days |
|
| Sphere, Then Toric | Experimental | Participants who received Spherical contact lenses first and Toric lenses after 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision1 for Astigmatism | Device | Daily disposable soft toric contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Enclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Richdale | University of Houston College of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Houston College of Optometry | Houston | Texas | 77204 | United States |
23 of 30 participants were randomized. Of those not randomized, 7 did not meet inclusion criteria.
30 participants were screened for eligibility between March and December 2021
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| ID | Title | Description |
|---|---|---|
| FG000 | Toric Then Spherical | Participants who received toric contact lenses first and spherical lenses after 10 days |
| FG001 | Spherical Then Toric | Participants who received spherical contact lenses first and toric lenses after 10 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
7 participants were screen failed.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | 23 participants who had completed the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | LogMAR | 10 +/- 2 days |
|
|
10 ± 2 days for each intervention
AE information was collected at each study visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Toric Contact Lens Wear | 23 participants had completed the study | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal staining | Eye disorders | Systematic Assessment | Corneal staining > Grade 2 (CCLRU scale) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Richdale OD, PhD | University of Houston | 713-743-1974 | richdale@uh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Aug 18, 2021 | Jan 14, 2022 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 20, 2021 | Jan 14, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Precision1 Sphere | Device | Daily disposable soft spherical contact lens |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | Posted | Mean | Standard Error | LogMAR | 10 +/- 2 days |
|
|
|
| 23 |
| 0 |
| 23 |
| 4 |
| 23 |
| EG001 | Spherical Contact Lens Wear | 23 participants had completed the study | 0 | 23 | 0 | 23 | 0 | 23 |
|
| Hordeolum | Eye disorders | Non-systematic Assessment |
|
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