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To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toric | Other | Implantation with the AcrySof® Toric intraocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® Toric intraocular lens | Device | Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rotational Stability | Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees. | 6 Months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Refractive Cylinder | The refractive astigmatism 6 months post-surgery, measured in diopters. | 6 Months post-surgery |
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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 |
non-randomized
79 eyes of 71 patients were enrolled into the study. 10 eyes (6 patients) were excluded from analysis for astigmatic keratomy outside of the protocol requirements
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| ID | Title | Description |
|---|---|---|
| FG000 | Toric | Implantation with the AcrySof® Toric intraocular lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Toric | Implantation with the AcrySof® Toric 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 | Age data collected for 69 participants; not provided for 2 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 | Rotational Stability | Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees. | 67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation. | Posted | Mean | Standard Error | degrees | 6 Months post-surgery |
|
|
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No adverse events were reported for the 71 patients participating in the 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 | Toric | Implantation with the 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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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Count of Participants |
| Participants |
|
| Sex: Female, Male | Gender data collected for 69 participants; not provided for 2 participants. | Count of Participants | Participants |
|
| Participants |
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| Secondary | Residual Refractive Cylinder | The refractive astigmatism 6 months post-surgery, measured in diopters. | 69 eyes (65 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. | Posted | Mean | Standard Error | diopters | 6 Months post-surgery |
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| 0 |
| 71 |
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| 71 |
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