Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess visual performance in patients with low levels (0.5-0.75 Diopters) of corneal astigmatism.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visual performance measures | Collection of visual performance measures in subjects with low levels of astigmatism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual performance measures | Other | Collection of visual performance measures in subjects with low levels of astigmatism. |
|
| Measure | Description | Time Frame |
|---|---|---|
| High and Low Contrast Acuity | Visual acuity differences between subjects tested with full correction and spherical equivalent (SE) correction at contrast levels of 9% and 25% (low contrast acuity) and 100% (high contrast acuity). LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA. These measurements were performed under photopic conditions by means of 9%, 25%, and 100% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts (Vector Vision). | Day of study visit |
| Contrast Sensitivity | Contrast Sensitivity (CS) differences between subjects tested with full correction & spherical equivalent (SE) correction. CS is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. CS is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. Testing was performed under photopic conditions (no glare) & mesopic conditions (with & without glare), and was measured at four spatial frequencies of 3, 6, 9, and 12 cycles per degree (cpd). A higher value for the logarithmic units translates to better CS. | Day of Study Visit |
| Reading Acuity and Speed | Reading Acuity and Speed differences between subjects tested with full correction and spherical equivalent (SE) correction. Reading Acuity was measured using the Radner reading charts, which are logarithmically scaled at different acuity levels (print sizes), and expressed in terms of logRAD (logrithmic Reading Acuity Determination). Reading speed was measured in words per minute (wpm). The results were presented as Average Reading Speed by Print Size (logRAD). | Day of Study Visit |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Subjects were selected from a single investigator's primary care clinic.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Visual Performance Measures | Collection of visual performance measures in subjects with low levels of astigmatism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Visual Performance Measures | Collection of visual performance measures in subjects with low levels of astigmatism. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | All patients were within the study inclusion/exclusion criteria and were within the ages of 50 and 75. No other specific age data is available. |
| 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 | High and Low Contrast Acuity | Visual acuity differences between subjects tested with full correction and spherical equivalent (SE) correction at contrast levels of 9% and 25% (low contrast acuity) and 100% (high contrast acuity). LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA. These measurements were performed under photopic conditions by means of 9%, 25%, and 100% contrast ETDRS (Early Treatment Diabetic Retinopathy Study) charts (Vector Vision). | Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected. | Posted | Mean | Standard Deviation | logMAR | Day of study visit |
|
Not provided
This study consisted of a single visit on a single day. No adverse event data were collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Visual Performance Measures | Collection of visual performance measures in subjects with low levels of astigmatism. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
Not provided
| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Number |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Contrast Sensitivity | Contrast Sensitivity (CS) differences between subjects tested with full correction & spherical equivalent (SE) correction. CS is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. CS is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. Testing was performed under photopic conditions (no glare) & mesopic conditions (with & without glare), and was measured at four spatial frequencies of 3, 6, 9, and 12 cycles per degree (cpd). A higher value for the logarithmic units translates to better CS. | Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected. | Posted | Mean | Standard Deviation | Logrithmic Units | Day of Study Visit |
|
|
|
| Primary | Reading Acuity and Speed | Reading Acuity and Speed differences between subjects tested with full correction and spherical equivalent (SE) correction. Reading Acuity was measured using the Radner reading charts, which are logarithmically scaled at different acuity levels (print sizes), and expressed in terms of logRAD (logrithmic Reading Acuity Determination). Reading speed was measured in words per minute (wpm). The results were presented as Average Reading Speed by Print Size (logRAD). | Data was collected for 40 eyes in 40 subjects. Only one operative eye of each subject was included in the study. If both eyes qualified, the dominant eye was selected. | Posted | Least Squares Mean | 95% Confidence Interval | words per minute | Day of Study Visit |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
No paper that incorporates Sponsor confidential information will be submitted for publication without Sponsor's prior written agreement.
| Title | Measurements |
|---|---|
|
| Mesopic 12 cpd |
|
| Mesopic with glare 3 cpd |
|
| Mesopic with glare 6 cpd |
|
| Mesopic with glare 9 cpd |
|
| Mesopic with glare 12 cpd |
|
| Photopic 3 cpd |
|
| Photopic 6 cpd |
|
| Photopic 9 cpd |
|
| Photopic 12 cpd |
|
| Title | Measurements |
|---|---|
|
| logRAD Line 0.2 |
|
| logRAD Line 0.3 |
|
| logRAD Line 0.4 |
|
| logRAD Line 0.5 |
|
| logRAD Line 0.6 |
|
| logRAD Line 0.7 |
|
| logRAD Line 0.8 |
|
| logRAD Line 0.9 |
|
| logRAD Line 1.1 |
|
| logRAD Line 1.2 |
|