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The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AcrySof Toric IOL | Experimental | AcrySof Toric Intraocular Lens (IOL) |
|
| AcrySof Natural IOL | Active Comparator | AcrySof Natural Intraocular Lens (IOL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® Toric IOL | Device | AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Visual Acuity (UCVA) | Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. | 6 Months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire Results | Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best). | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center | Fort Worth | Texas | 76134 | United States |
Randomized
60 cataract patients were enrolled into the study
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| ID | Title | Description |
|---|---|---|
| FG000 | AcrySof Toric IOL | AcrySof Toric Intraocular Lens |
| FG001 | AcrySof Natural IOL | AcrySof Natural Intraocular Lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AcrySof Toric IOL | AcrySof Toric Intraocular Lens |
| BG001 | AcrySof Natural IOL | AcrySof Natural Intraocular Lens |
| 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 Visual Acuity (UCVA) | Uncorrected Visual Acuity (UCVA) from surgery 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 after 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 | AcrySof Toric IOL | AcrySof Toric Intraocular Lens |
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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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| AcrySof Natural | Device | AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Questionnaire Results | Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best). | Posted | Mean | Standard Error | Units on a scale | 6 Months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | AcrySof Natural IOL | AcrySof Natural Intraocular Lens | 0 | 30 | 0 | 30 |
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