Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR Aspheric +4 | Active Comparator | ACRYSOF ReSTOR Aspheric +4 Model SN6AD3 |
|
| Tecnis MF | Active Comparator | Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900 |
|
| Acri.LISA | Active Comparator | Meditec Acri.LISA Intraocular Lens (IOL) Model 366D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReSTOR | Device | Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate | Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). 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 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Subject eligibility was determined at the pre-operative visit.
Subjects 18 years or older of either sex and any race; bilateral diagnosis of cataracts.
There were no patients that received implantation of the Tecnis Multifocal lens.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ReSTOR Aspheric +4 | Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3 |
| FG001 | Acri LISA IOL | Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D |
| FG002 | Tecnis MF | Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ReSTOR Aspheric +4 | Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3 |
| BG001 | Acri LISA IOL | Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D |
| 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 | Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate | Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity. | Posted | Mean | Standard Deviation | logMAR | 6 months |
|
Not provided
There were no adverse events to report.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ReSTOR Aspheric +4 | Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tecnis | Device | Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL) |
|
| Acri.LISA | Device | Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL) |
|
| Defocus Curve | Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. 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 post-operative |
| 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 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 | Defocus Curve | Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. 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 post-operative |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Acri LISA IOL | Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D | 0 | 22 | 0 | 22 |
No paper that incorporates Sponsor Condfidential information will be submitted for publication without Sponsor's prior written agreement.
| Contrast Sensitivity 6 cpd |
|
| Contrast Sensitivity 12 cpd |
|
| Contrast Sensitivity 18 cpd |
|
| Mesopic Conditions, 1.5 cpd |
|
| Mesopic Conditions, 3 cpd |
|
| Mesopic Conditions, 6 cpd |
|
| Mesopic Conditions, 12 cpd |
|
| Mesopic Conditions, 18 cpd |
|
| Mesopic Conditions w/glare, 1.5 cpd |
|
| Mesopic Conditions w/glare, 3 cpd |
|
| Mesopic Conditions w/glare, 6 cpd |
|
| Mesopic Conditions w/glare, 12 cpd |
|
| Mesopic Conditions w/glare, 18 cpd |
|
| Negative Defocus Curve, -4.0 Diopter |
|
| Negative Defocus Curve, -3.5 Diopter |
|
| Negative Defocus Curve, -3.0 Diopter |
|
| Negative Defocus Curve, -2.5 Diopter |
|
| Negative Defocus Curve, -2.0 Diopter |
|
| Negative Defocus Curve, -1.5 Diopter |
|
| Negative Defocus Curve, -1.0 Diopter |
|
| Negative Defocus Curve, -0.5 Diopter |
|
| Negative Defocus Curve, 0.0 Diopter |
|
| Positive Defocus Curve, 2.0 Diopter |
|
| Positive Defocus Curve, 1.5 Diopter |
|
| Positive Defocus Curve, 1.0 Diopter |
|
| Positive Defocus Curve, 0.5 Diopter |
|
| Positive Defocus Curve, 0.0 Diopter |
|