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The purpose of this study is to describe rates of spatial distortions related to intraocular lens (IOL) misalignment for ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 when implanted bilaterally into the capsular bag following phacoemulsification in adult patients with bilateral cataract and regular corneal astigmatism. Subjects were implanted with the Model SN60T9 in the first operative (study) eye and either Model SN60T9 or Model SN60T8 in the second operative eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toric Intraocular Lens | Experimental | ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Models SN60T9/SN60T8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACRYSOF® Single-Piece NATURAL Toric IOL Model SN60T9 and Model SN60T8. | Device | ACRYSOF® Single-Piece Toric NATURAL Intraocular Lens (IOL) Model SN60T9 in the first eye and either the ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 or Model SN60T8 in the second eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment | Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate & frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions. | Before Surgery and 180 days after second eye implant |
| Reduction of Cylinder | Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively. | 6 months after surgery on second eye |
| Lens Axis Misalignment | Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye. | Time of 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Toric Intraocular Lens | ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Toric Intraocular Lens | ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 |
| 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 | Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment | Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate & frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions. | Per protocol, one subject was excluded from this analysis due to a secondary surgical intervention. | Posted | Number | Participants | Before Surgery and 180 days after second eye implant |
|
6 months
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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 Intraocular Lens | ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Secondary Surgical Intervention | Eye disorders | Systematic Assessment | One subject underwent a secondary surgical intervention (IOL repositioning) in the first eye to resolve refractive error due to inaccurate pre-operative manual keratometry. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 888-451-3937; 817-568-6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| Participants |
|
| Gender | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Reduction of Cylinder | Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively. | All implanted subjects were included in this analysis. | Posted | Mean | 95% Confidence Interval | Percent reduction of cylinder | 6 months after surgery on second eye |
|
|
|
| Primary | Lens Axis Misalignment | Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye. | All implanted subjects were included in this analysis. | Posted | Mean | Full Range | Degrees | Time of surgery |
|
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| 1 |
| 15 |
| 0 |
| 15 |
|
Per clinical protocol confidentiality/study publication specifications all data discoveries arising out of the study, patentable of nonpatentable, shall be the sole property of Alcon Inc. Alcon reserves the right of prior review of any publication or presentation of information related to the study.