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To assess posterior capsule opacification (PCO) in patients implanted with either the AcrySof SN60AT lens or the AcrySof SN60WF lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SN60AT | Experimental | Implantation with the AcrySof Intraocular Lens Model SN60AT |
|
| SN60WF | Active Comparator | Implantation with the AcrySof Intraocular Lens Model SN60WF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SN60AT | Device | Implantation with the AcrySof Intraocular Lens Model SN60AT following cataract removal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Posterior Capsule Opacification (PCO) | Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area. | 2 years after surgery |
| 100% LogMAR Best Corrected Visual Acuity (BCVA) | Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. | 24 months after surgery |
| 9% LogMAR Best Corrected Visual Acuity (BCVA) | Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. | 24 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
Uncomplicated age-related bilateral cataract with the potential to see 20/40 or better in each eye
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| ID | Title | Description |
|---|---|---|
| FG000 | SN60AT | Implantation with the AcrySof Intraocular Lens Model SN60AT |
| FG001 | SN60WF | Implantation with the AcrySof Intraocular Lens Model SN60WF |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SN60AT | Implantation with the AcrySof Intraocular Lens Model SN60AT |
| BG001 | SN60WF | Implantation with the AcrySof Intraocular Lens Model SN60WF |
| 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 | Posterior Capsule Opacification (PCO) | Thickening and opacification of the transparent membrane on which the intraocular lens is placed assessed by taking a digital retroillumination image of each eye with a dedicated retroillumination camera system. The photographs were analyzed with POCO software to measure the percentage area of PCO in the capsulorhexis area. | Data for all patients completing the 24 month visit were analyzed. | Posted | Mean | Standard Deviation | Percentage of PCO | 2 years 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 | SN60AT | Implantation with the AcrySof Intraocular Lens Model SN60AT |
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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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| SN60WF | Device | Implantation with the AcrySof Intraocular Lens Model SN60WF following cataract removal. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | 100% LogMAR Best Corrected Visual Acuity (BCVA) | Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under high contrast (100%), which means that there was maximum contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. | Data for all patients completing the 24 month visit were analyzed. | Posted | Mean | Standard Deviation | LogMAR | 24 months after surgery |
|
|
|
| Primary | 9% LogMAR Best Corrected Visual Acuity (BCVA) | Best spectacle corrected vision was recorded for each eye of the patients at above follow up visits. The Visual Acuity (VA) measurement was taken under low contrast (9%), which means that there was low contrast between the letters on the chart and the background. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. | Data for all patients completing the 24 month visit were analyzed. | Posted | Mean | Standard Deviation | LogMAR | 24 months after surgery |
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|
|
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | SN60WF | Implantation with the AcrySof Intraocular Lens Model SN60WF | 0 | 52 | 0 | 52 |
Publications relating to the study should not be made without the Sponsor's prior written consent and not prior to the completion of the study. The sponsor shall be notified in writing at least 60 days prior to submission of any intention on the part of the Investigator to publish and shall provide the sponsor an opportunity to comment on any proposed publications.