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Randomized, parallel group, subject masked, multi-center six (6) month follow-up study comparing ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 implanted in both eyes to ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR Aspheric +3.0D | Experimental | ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens |
|
| ReSTOR Aspheric +4.0D | Active Comparator | ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens | Device | Intraocular Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) | Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance Corrected Distance Visual Acuity | Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). | 3 months post-operative |
| Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm) |
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Inclusion:
Exclusion:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call Center for Locations | Fort Worth | Texas | 76134 | United States |
Subjects were examined to ensure inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study were enrolled. Subject numbers were assigned after obtaining consent meeting inclusion/exclusion criteria. Subjects were considered enrolled once implanted in the first operative eye.
Only adult subjects of either gender or any race in need of cataract extraction in both eyes were considered for enrollment. 280 subjects were implanted bilaterally with either the ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 or the ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 based upon a 1:1 randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACRYSOF® ReSTOR® +3.0 | ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens |
| FG001 | ACRYSOF® ReSTOR® Aspheric +4.0 | ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACRYSOF® ReSTOR® +3.0 | ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens |
| BG001 | ACRYSOF® ReSTOR® Aspheric +4.0 | ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens |
| 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 | Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) | Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity. | Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis). | Posted | Jan 2009 | Mean | 95% Confidence Interval | logMAR | 3 months |
|
Up to six months after cataract surgery.
Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the 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 | ACRYSOF® ReSTOR® +3.0 (First Eyes) | ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - First eye implanted only |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypopyon | Eye disorders | Systematic Assessment |
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Data from one investigator, who implanted 20 subjects, were excluded from analysis due to non compliance with data collection and documentation. This resulted in 280 implanted subjects that were considered evaluable.
| 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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| ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens | Device | Intraocular Lens |
|
Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). |
| 3 months post-operative |
| Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm) | Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). | 3 months post-operative |
| Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm) | Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). | 3 months post-operative |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | ACRYSOF® ReSTOR® Aspheric +4.0 | ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens |
|
|
| Secondary | Binocular Distance Corrected Distance Visual Acuity | Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). | Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis). | Posted | Jan 2009 | Mean | 95% Confidence Interval | logMAR | 3 months post-operative |
|
|
|
| Secondary | Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm) | Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). | Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis). | Posted | Jan 2009 | Mean | 95% Confidence Interval | logMAR | 3 months post-operative |
|
|
|
| Secondary | Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm) | Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). | Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis). | Posted | Jan 2009 | Mean | 95% Confidence Interval | logMAR | 3 months post-operative |
|
|
|
| Secondary | Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm) | Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). | Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis). | Posted | Jan 2009 | Mean | 95% Confidence Interval | logMAR | 3 months post-operative |
|
|
|
| 6 |
| 153 |
| 0 |
| 153 |
| EG001 | ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes) | ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - First eye implanted only | 2 | 147 | 0 | 147 |
| EG002 | ACRYSOF® ReSTOR® +3.0 (Second Eyes) | ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - Second eye implanted only | 2 | 151 | 0 | 151 |
| EG003 | ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes) | ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - Second eye implanted only | 3 | 143 | 0 | 143 |
| Endophthalmitis | Eye disorders | Systematic Assessment |
|
| Macular Edema | Eye disorders | Systematic Assessment |
|
| Lens Dislocation | Eye disorders | Systematic Assessment |
|
| Surgical reintervention (SI) | Surgical and medical procedures | Systematic Assessment | Some eyes experienced SI and more than 1 SAE. SN5AD1 (1st Eye): 1 patient - hypopyon, endophthalmitis; 1 patient - lens dislocation; and 1 patient - after the close of the study. SN6AD3 (1st Eye): 1 patient - later had macular edema. |
|
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