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The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acrysof ReSTOR IOL | Experimental | AcrySof ReSTOR Intraocular lens (IOL) implanted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESTOR IOL Model SA60D3 | Device | Implanted into the study eye following cataract extraction surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Near Uncorrected Visual Acuity(UCVA | Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity. | 6 months after surgery of 2nd eye |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast Sensitivity | 6 months after sugery of the 2nd eye |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center | Fort Worth | Texas | 76134 | United States |
Open-label, single arm and nonrandomized
Eligible patients with bilateral cataract were implanted with ReSTOR lens and followed up for 6-month after the 2nd eye implantation
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| ID | Title | Description |
|---|---|---|
| FG000 | AcrySof ReSTOR IOL | Acrysof ReSTOR Intraocular Lens (IOL) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AcrySof ReSTOR IOL | Acrysof ReSTOR Intraocular Lens (IOL) |
| 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 | Near Uncorrected Visual Acuity(UCVA | Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity. | Posted | Mean | Standard Deviation | logMAR | 6 months after surgery of 2nd eye |
|
|
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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 IOL | Acrysof ReSTOR Intraocular Lens (IOL) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benny Li, PhD | Alcon Research, Ltd. | +86 21 6375 8762 | Benny.Li@Alconlabs.com |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Contrast Sensitivity | Not Posted | 6 months after sugery of the 2nd eye | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
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