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The objective of this study is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR Aspheric IOL | Experimental | Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof ReSTOR Aspheric IOL | Device | Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected and Best Corrected Visual Acuities (Near and Distance) | Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. | 6 Months Following Cataract 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 |
Open-label, single arm, non-randomized
34 eligible patients were enrolled into the study
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| ID | Title | Description |
|---|---|---|
| FG000 | ReSTOR Aspheric | Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ReSTOR Aspheric | Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Uncorrected and Best Corrected Visual Acuities (Near and Distance) | Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. | Posted | Mean | Standard Deviation | logMAR | 6 Months Following Cataract Surgery |
|
|
1 Day, 1 Month, 3 Months, and 6 Months following cataract surgery.
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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 Aspheric | Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glare | Eye disorders |
|
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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 |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 34 |
| 1 |
| 34 |
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