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The purpose of this study is to evaluate the effect that placement and power of the AcrySof Toric has on post-operative visual acuity and spectacle independence for distance vision. This will be determined by comparing manifest refraction pre-operatively and post-operatively and by evaluating the rotational stability of the lens over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AcrySof Toric IOL | Experimental | AcrySof Toric Intraocular Lens (IOL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof Toric IOL | Device | Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (VA) | Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). | Pre-operative, 1 month, 3 month, and 6 month post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Spectacle Independence | Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit | 6 months post-operative |
| IOL Rotation | Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation. |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria Before Surgery - Ocular
Exclusion Criteria During Surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center | 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 one or both eyes.
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| ID | Title | Description |
|---|---|---|
| FG000 | AcrySof Toric IOL | Implantation of the AcrySof Toric Intraocular lens (IOL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | AcrySof Toric IOL | Implantation of the AcrySof Toric 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 | Visual Acuity (VA) | Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). | Posted | Mean | Standard Deviation | logMAR | Pre-operative, 1 month, 3 month, and 6 month post-operative |
|
|
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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 | Implantation of the AcrySof Toric Intraocular lens (IOL) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lens Repositioning | Surgical and medical procedures | Systematic Assessment | Repositioning of the intraocular lens during outpatient procedure. |
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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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| 6 months post-operative |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Spectacle Independence | Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit | Posted | Number | Percentage of participants | 6 months post-operative |
|
|
|
| Secondary | IOL Rotation | Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation. | Posted | Number | Percentage of Participants | 6 months post-operative |
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| 0 |
| 120 |
| 1 |
| 120 |
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