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The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR +3 | Experimental | Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction |
|
| Tecnis MF | Active Comparator | Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReSTOR +3 | Device | Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Defocus Curve | A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". | 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Center of North Florida | Panama City | Florida | 32405 | United States | ||
| Carolina Eye Care Physicians |
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria.
Bilateral diagnosis of cataracts of subjects >21 years of age
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| ID | Title | Description |
|---|---|---|
| FG000 | ReSTOR +3 | Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction |
| FG001 | Tecnis MF | Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ReSTOR +3 | Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction |
| BG001 | Tecnis MF | Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction |
| 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 | Defocus Curve | A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". | In the ReSTOR +3 population, 1 subject did not complete the assessment at -5.00 D; therefore, only 32 subjects were used for this measure. | Posted | Mean | Standard Deviation | LogMAR | 3 months after surgery |
|
Adverse events were collected at all study visits.
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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 | ReSTOR +3 | Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| Tecnis MF | Device | Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction |
|
| Charleston |
| South Carolina |
| 29414 |
| United States |
| Whitsett Vision Group | Houston | Texas | 77055 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Tecnis MF | Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction | 0 | 30 | 0 | 30 |
The existence of this clinical study is confidential and should not be discussed with persons outside of the study. You shall hold confidential, and not disclose directly or indirectly to any third party other than those persons involved in the study who have a need to know, the protocol, the data arising out of the study, and any other information related to the study or to Alcon's products or research programs that is provided by Alcon to you (the "Confidential Information").