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The objective of this study is to compare the contrast sensitivity, high and low contrast visual acuity (VA), glare meter outcomes, and subject satisfaction with three different FDA-approved intraocular lenses (IOLs) designed to improve distance, intermediate, and near vision following lens extraction in adults at least 40 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crystalens AO | Experimental | Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens |
|
| ReSTOR 3.0 | Active Comparator | An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. |
|
| AMO Tecnis Multifocal | Active Comparator | A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crystalens AO | Device | Bausch & Lomb model silicone multi-piece accommodating IOL. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) |
| Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) |
| Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) |
| Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tes Ignacio, MD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Eye Institute | Makati City | 1200 | Philippines |
186 participant eyes were enrolled in this study 154 participant eyes completed the study. Participants underwent bilateral phacoemulsification and IOL implantation. Participants were randomized to treatment groups prior to surgery.
This study was an evaluation of three United States Food and Drug Administration (FDA) approved IOLs. A total of 93 participants(186 eyes) were enrolled at one investigative site in the Philippines. First participant was enrolled 7/15/2010 and last participant exited the study 4/28/2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crystalens AO | Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens |
| FG001 | ReSTOR 3.0 | An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. |
| FG002 | AMO Tecnis Multifocal | A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Crystalens AO | Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens |
| BG001 | ReSTOR 3.0 | An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. |
| 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 | Monocular Mesopic Contrast Sensitivity Without Glare (1.5, 3 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) | eyes | Participants |
|
120-180 days
Adverse events measured by 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 | Crystalens AO | Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased Intraocular Pressure | Eye disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Omid Khodai, OD,RAC | Bausch & Lomb Incorporated | (949) 521-7894 | omid.khodai@bausch.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ReSTOR 3.0 |
| Device |
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. |
|
| AMO Tecnis Multifocal | Device | The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL. |
|
| Postoperative visit 3 (day 30-60) |
| Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Postoperative visit 3 (day 30-60) |
| Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) |
| Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) |
| Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) |
| Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) |
| Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) |
| Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) |
| Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) |
| Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 3 (day 30-60) |
| Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Postoperative visit 4 (day 120-180) |
| Withdrawal by Subject |
|
| Surgical complications |
|
| BG002 | AMO Tecnis Multifocal | A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ReSTOR 3.0 |
An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. |
| OG002 | AMO Tecnis Multifocal | A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL |
|
|
| Primary | Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set, non-missing | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) | eyes | Participants |
|
|
|
| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | In two eye (Binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) |
|
|
|
| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) |
|
|
|
| Primary | Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set, non-missing | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) | eyes | Participants |
|
|
|
| Primary | Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set, non-missing | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) | eyes | Participants |
|
|
|
| Primary | Monocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) | eyes | Participants |
|
|
|
| Primary | Monocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) | eyes | Participants |
|
|
|
| Primary | Monocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) | eyes | Participants |
|
|
|
| Primary | Monocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | A single eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) | eyes | Participants |
|
|
|
| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) |
|
|
|
| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) |
|
|
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| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare(1.5, 3 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) |
|
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| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare(6 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) |
|
|
|
| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare(12 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) |
|
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| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare(18 Cycles/Degree) | In two eyes (binocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full Analysis Set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) |
|
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| Secondary | Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) | eyes | Participants |
|
|
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| Secondary | Monocular Mesopic Contrast Sensitivity With Glare (3 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) | eyes | Participants |
|
|
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| Secondary | Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) | eyes | Participants |
|
|
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| Secondary | Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) | eyes | Participants |
|
|
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| Secondary | Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (day 30-60) | eyes | Participants |
|
|
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| Secondary | Monocular Mesopic Contrast Sensitivity With Glare(1.5 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) | eyes | Participants |
|
|
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| Secondary | Monocular Mesopic Contrast Sensitivity With Glare(3 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) | eyes | Participants |
|
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| Secondary | Monocular Mesopic Contrast Sensitivity With Glare(6 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) | eyes | Participants |
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| Secondary | Monocular Mesopic Contrast Sensitivity With Glare(12 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) | eyes | Participants |
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| Secondary | Monocular Mesopic Contrast Sensitivity With Glare(18 Cycles/Degree) | In one eye (monocular) in dim light (mesopic) measuring contrast sensitivity; The participant is presented with a sine-wave grating target of a given spatial frequency (cycles/degree of visual angle) where the smaller the number of cycles/degree the wider apart the gradations (vertical lines of grayness). The participant's ability to detect changes in contrast is determined. Higher mean indicates improved contrast sensitivity. | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 (day 120-180) | eyes | Participants |
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| 0 |
| 53 |
| 12 |
| 53 |
| EG001 | ReSTOR 3.0 | An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region. | 0 | 54 | 5 | 54 |
| EG002 | AMO Tecnis Multifocal | A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL | 0 | 51 | 6 | 51 |
| Cystoid Macular Edema | Eye disorders | MedDRA (12.0) | Systematic Assessment |
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All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s)after the review by, and in consultation and agreement with the Sponsor.
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