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This study will involve up to 20 bilateral patients per surgeon. Patients will be assessed pre-operatively, and at subsequent visits (following the implantation of the intraocular lens in the second eye) at 1 week, 1 month, 3 months and 6 months post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AcrySof® ReSTOR® Aspheric IOL | Experimental | AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® ReSTOR® Aspheric IOL | Device | AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) implanted into the study eye following the cataract extraction surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. | pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Spectacle Independence | Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported. | pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
Subjects >21 years of age, either sex, and any race. Diagnosis of cataracts in both eyes. 27-Jun-2007 to 20-May-2009
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| ID | Title | Description |
|---|---|---|
| FG000 | AcrySof® ReSTOR® Aspheric IOL | AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | AcrySof® ReSTOR® Aspheric IOL | AcrySof® ReSTOR® Aspheric 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, Categorical | Count of Participants |
| 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 | Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. | Posted | Mean | Standard Deviation | logMAR | pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery |
|
|
June 27, 2007 (First Subject, first visit) through August 1, 2009 (Last subject, last 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 | AcrySof® ReSTOR® Aspheric IOL | AcrySof® ReSTOR® Aspheric 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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| Participants |
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| Gender | Gender data not collected for 1 patient. | Number | participants |
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| Participants |
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| Secondary | Spectacle Independence | Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported. | Patient population was not consistent throughout the study. Number of patients analyzed at each visit is as follows: Preoperative n=76, Week 1 n=61, 1 Month n=71, 3 Months n=70, 6 Months n=68. | Posted | Number | Percentage of Participants | pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery |
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| 0 |
| 76 |
| 0 |
| 76 |
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| Title | Measurements |
|---|---|
|
| 3 Months Postoperative |
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| 6 Months Postoperative |
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