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To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons throughout the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR | AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReSTOR | Device | Patients were implanted with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) in one or both eyes for treatment of cataract. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity. | 1 week to 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast Sensitivity | Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects were selected from primary care clinics.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Subjects eligibility was determined at the preoperative visit.
Subjects 18 years of age and older of either sex and any race. Diagnosis of cataracts in one or both eyes.
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| ID | Title | Description |
|---|---|---|
| FG000 | ReSTOR | Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ReSTOR | Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age data received on only 124 subjects. |
| 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 | Visual Acuity | Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity. | Posted | Mean | Standard Deviation | logMAR | 1 week to 10 months |
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Adverse events were not collected for this study because there was no intervention. This was a data collection only study.
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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 | ReSTOR | Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 1 week to 10 months |
| Number |
| participants |
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| Sex/Gender, Customized | Gender data received on only 133 subjects | Number | participants |
|
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| Secondary | Contrast Sensitivity | Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity. | contrast sensitivity data was received for only 51 of 146 patients. | Posted | Mean | Standard Deviation | log units | 1 week to 10 months |
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No paper that incorporates Sponsor Confidential information will be submitted for publication without Sponsor's prior written agreement.
| Title | Measurements |
|---|---|
|
| Photopic condition at 12 cpd |
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| Photopic condition at 18 cpd |
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| Mesopic condition at 1.5 cpd |
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| Mesopic condition at 3 cpd |
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| Mesopic condition at 6 cpd |
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| Mesopic condition at 12 cpd |
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| Mesopic condition at 18 cpd |
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| Mesopic with glare condition at 1.5 cpd |
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| Mesopic with glare condition at 3 cpd |
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| Mesopic with glare condition at 6 cpd |
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| Mesopic with glare condition at 12 cpd |
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| Mesopic with glare condition at 18 cpd |
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