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Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monofocal | Active Comparator | Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye |
|
| Phakic | Active Comparator | Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReSTOR | Device | AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast Sensitivity | Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity. | 6 Months |
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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 |
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. This study was not randomized.
This is a retrospective study that required patients with unilateral implantation of the AcrySof ReSTOR Intraocular Lens (IOL). Patients were to be free of conditions or ocular co-morbidities that may affect visual acuity.
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| ID | Title | Description |
|---|---|---|
| FG000 | Monofocal | Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye |
| FG001 | Phakic | Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Monofocal | Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye |
| BG001 | Phakic |
| 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 | Uncorrected Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. | Posted | Mean | Standard Deviation | LogMar | 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 | Monofocal | Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye |
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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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| Patient Satisfaction | Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied). | 6 Months Postoperative |
| Spectacle Independence | The percentage of patients reporting spectacle independence (no longer needing to wear glasses). | 6 Months |
Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Contrast Sensitivity | Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity. | Posted | Mean | Standard Deviation | Log Units | 6 Months |
|
|
|
| Secondary | Patient Satisfaction | Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied). | Posted | Mean | Standard Deviation | Units on a Scale | 6 Months Postoperative |
|
|
|
| Secondary | Spectacle Independence | The percentage of patients reporting spectacle independence (no longer needing to wear glasses). | Posted | Number | Percentage of Participants | 6 Months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Phakic | Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending | 0 | 32 | 0 | 32 |
Specify: No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.
| Mesopic w/Glare CS, 3 cpd |
|
| Photopic CS, 6 cpd |
|
| Mesopic CS, 6 cpd |
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| Mesopic w/Glare CS, 6 cpd |
|
| Photopic CS, 12 cpd |
|
| Mesopic CS, 12 cpd |
|
| Mesopic w/Glare CS, 12 cpd |
|
| Photopic CS, 18 cpd |
|
| Mesopic CS, 18 cpd |
|
| Mesopic w/Glare CS, 18 cpd |
|