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The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SN6AD1 | Experimental | AcrySof ReSTOR Model SN6AD1 Intraocular Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 | Device | Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Intermediate Visual Acuity | Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. | 1 year after surgery |
| Uncorrected Distance Visual Acuity | Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. | 1 year after surgery |
| Uncorrected Near Visual Acuity | Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. | 1 year after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hayashi Eye Hospital | Fukuoka | Fukuoka | 812-0011 | Japan |
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 in need of cataract extraction in both eyes were considered for enrollment. 64 subjects were implanted bilaterally with the ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
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| ID | Title | Description |
|---|---|---|
| FG000 | SN6AD1 | ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SN6AD1 | ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Intermediate Visual Acuity | Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. | One patient dropped out after the visit 6 months following surgery but before the 1 year visit. | Posted | Mean | Full Range | Decimal Visual Acuity | 1 year after surgery |
|
From time of surgery to 1 year following surgery.
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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 | SN6AD1 | ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | MedDRA Ver.12.0, LLT | No causality with the test article |
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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 |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Uncorrected Distance Visual Acuity | Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. | One patient dropped out after the visit 6 months following surgery but before the 1 year visit. | Posted | Mean | Full Range | Decimal Visual Acuity | 1 year after surgery |
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|
|
| Primary | Uncorrected Near Visual Acuity | Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. | One patient dropped out after the visit 6 months following surgery but before the 1 year visit. | Posted | Mean | Full Range | Decimal Visual Acuity | 1 year after surgery |
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| 1 |
| 64 |
| 0 |
| 64 |
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