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The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral implantation) at Month 3 following the second eye surgery.
Each subject will complete a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Day 30 and Day 90 after the second implantation). The second implantation will occur between 1 and 45 days of the first. If the first eye is not implanted during surgery, the second eye is not eligible. lf both eyes are not implanted with the assigned IOL, the subject will be followed for safety evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral | Experimental | AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation |
|
| Contralateral | Active Comparator | AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1, contralateral implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] | Device | Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm) | Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. | Day 90 from second eye implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm) | VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. | Day 90 from second eye implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magda Michna, PhD | Alcon Research | Study Director |
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Of the 112 subjects enrolled, 9 were discontinued prior to randomization as screen failures. This reporting group includes all implanted subjects (103).
Subjects were recruited from 8 investigative sites located outside the USA, including Argentina (1), Chile (1), Germany (2), Netherlands (2), and Spain (2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilateral | AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation |
| FG001 | Contralateral | AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all implanted subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilateral | AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation |
| BG001 | Contralateral | AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm) | Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. | This analysis population includes all subjects with both eyes implanted. | Posted | Mean | Standard Deviation | logMAR | Day 90 from second eye implantation |
|
Adverse events (AEs) were collected for the duration of the study (Nov2012-Aug2013). This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the medical device. AEs were collected as solicited comments and as observations by the study Investigator as outlined in the protocol.
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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 | Bilateral | AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Magda Michna, Expert Clinical Lead, Surgical | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 | Device | Multifocal IOL implanted for long-term use over the lifetime of the cataract patient |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Contralateral |
AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation |
|
|
| Secondary | Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm) | VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity. | This analysis population includes all subjects with both eyes implanted. | Posted | Mean | Standard Deviation | logMAR | Day 90 from second eye implantation |
|
|
|
| 0 |
| 53 |
| 3 |
| 53 |
| EG001 | Contralateral | AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation | 2 | 50 | 3 | 50 |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.