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Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model SN60WF | Active Comparator | Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) |
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| Model MA60AC | Active Comparator | Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Model SN60WF | Device | Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal. |
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| Measure | Description | Time Frame |
|---|---|---|
| Posterior Capsule Opacification (PCO) | Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective. | Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Study Locations | Fort Worth | Texas | 76134 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Model SN60WF | Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) |
| FG001 | Model MA60AC | Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Model MA60AC | Device | Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Model SN60WF | Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) |
| BG001 | Model MA60AC | Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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) | Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective. | Posted | Mean | Standard Deviation | Units on a scale | Up to 3 years |
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Adverse events were not collected for this 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 | Model SN60WF | Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) | 0 | 81 | 0 | 81 | ||
| EG001 | Model MA60AC | Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) | 0 | 81 | 0 | 81 |
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All study data is held confidential and not be disclosed to a 3rd party without written consent from Alcon Laboratories for a period of 3 years.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| >=65 years |
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| Male |
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