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The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crystalens AO | Experimental | Eligible subjects to undergo small incision cataract surgery and were implanted with the Crystalens AO bilaterally. |
|
| ReSTOR | Active Comparator | Eligible subjects to undergo small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. |
|
| Tecnis Multifocal IOL | Active Comparator | Eligible subjects to undergo small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crystalens AO | Device | Crystalens AO surgically implanted bilaterally. Study observation up to 180 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 3 (2-3 months) |
| Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 3 (2-3 months) |
| Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 3 (2-3 months) |
| Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 3 (2-3 months) |
| Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omid Khodai, OD, RAC | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Inc | Aliso Viejo | California | 92656 | United States |
Seventy eight participants (156 eyes) were enrolled in the study. 148 eyes were analyzed in both the full analysis set and the per protocol set.
This study took place at two investigative sites in the United States, with the first participant undergoing cataract surgery on 5/18/2010 and last participant completed the study on 6/27/2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crystalens AO | Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days. |
| FG001 | ReSTOR | Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days. |
| FG002 | Tecnis Multifocal IOL | Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL :Tecnis surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Cataract Surgery |
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| ||||||||||||||||||
| Post-Cataract Surgery |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Crystalens AO | Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days. |
| BG001 | ReSTOR |
| 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 | Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (2-3 months) | eyes | Participants |
|
6 months
Serious adverse events were measured by participant where as Other adverse events were 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 | Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally. Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous hemorrhage | Eye disorders | MedDRA (12.0) | Systematic Assessment | Mild vitreous hemorrhage, resolved in 38 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal Edema | Eye disorders | MedDRA (12.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Quintus Ngumah, OD, PhD | Bausch & Lomb Incorporated | (973) 360-6450 | Quintus.Ngumah@bausch.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ReSTOR | Device | ReSTOR surgically implanted bilaterally. Study observation up to 180 days. |
|
| Tecnis Multifocal IOL | Device | Tecnis surgically implanted bilaterally. Study observation up to 180 days. |
|
| Postoperative visit 4 ( 4-6 months) |
| Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 4 ( 4-6 months) |
| Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 4 ( 4-6 months) |
| Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 4 ( 4-6 months) |
| Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Postoperative visit 4 ( 4-6 months) |
| Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 3 (2-3 months) |
| Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Visit 4 (4-6 months) |
| Optical Scatter | Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention. | Visit 3 (2-3 months) |
| Optical Scatter | Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention. | Visit 4 (4-6 months) |
| Monocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Visit 3 (2-3 months) |
| Monocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Visit 4 (4-6 months) |
| Binocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Visit 3 (2-3 months) |
| Binocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Visit 4 (4-6 months) |
| Manifest Refraction | Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder. | Visit 3 (2-3 Months) |
| Manifest Refraction | Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder. | Visit 4 (4-6 Months) |
| Uncorrected Distance Visual Acuity | High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches | Visit 3 (2-3 months) Visit 4 (4-6 months) |
| Best-corrected Distance Visual Acuity | High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA) | Visit 3 (2-3 months) Visit 4 (4-6 months) |
| NOT COMPLETED |
|
|
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days. |
| BG002 | Tecnis Multifocal IOL | Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days. |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ReSTOR |
Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days. |
| OG002 | Tecnis Multifocal IOL | Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days. |
|
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| Primary | Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (2-3 months) | eyes | Participants |
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| Primary | Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (2-3 months) | eyes | Participants |
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| Primary | Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 3 (2-3 months) | eyes | Participants |
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| Primary | Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 ( 4-6 months) | eyes | Participants |
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| Primary | Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 ( 4-6 months) | eyes | Participants |
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| Primary | Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 ( 4-6 months) | eyes | Participants |
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| Primary | Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 ( 4-6 months) | eyes | Participants |
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| Primary | Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Postoperative visit 4 ( 4-6 months) | eyes | Participants |
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| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full set analysis | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) |
|
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| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) |
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| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) |
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| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) |
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| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) |
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| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) |
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| Secondary | Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) |
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| Secondary | Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) | eyes | Participants |
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| Secondary | Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) | eyes | Participants |
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| Secondary | Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) | eyes | Participants |
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| Secondary | Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) | eyes | Participants |
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| Secondary | Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) | eyes | Participants |
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| Secondary | Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) | eyes | Participants |
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| Secondary | Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) | eyes | Participants |
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| Secondary | Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) | eyes | Participants |
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| Secondary | Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) | eyes | Participants |
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| Secondary | Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) | eyes | Participants |
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| Secondary | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) |
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| Secondary | Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) |
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| Secondary | Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) |
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| Secondary | Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 3 (2-3 months) |
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| Secondary | Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) |
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| Secondary | Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) |
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| Secondary | Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) |
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| Secondary | Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree | Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) with glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity | Full analysis set | Posted | Mean | Standard Deviation | log contrast sensitivity units | Visit 4 (4-6 months) |
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| Secondary | Optical Scatter | Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Visit 3 (2-3 months) | eyes | Participants |
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| Secondary | Optical Scatter | Objective scatter index (OSI) was assessed using the Optical Quality Analysis System(OQAS) and summarized as a continuous variable. For this assessment, an OSI score of 1 or less represents good quality vision, 1-2 indicates some degradation but otherwise normal vision, 2-3 significant light scatter possibly requiring treatment, and scores over 4 severely compromised vision requiring intervention. | Posted | Mean | Standard Deviation | units on a scale | Visit 4 (4-6 months) | eyes | Participants |
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| Secondary | Monocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Visit 3 (2-3 months) | eyes | Participants |
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| Secondary | Monocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Visit 4 (4-6 months) | eyes | Participants |
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| Secondary | Binocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Visit 3 (2-3 months) |
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| Secondary | Binocular Halo and Starburst | Halo and starburst (both monocular and binocular) were measured using a glarometer on integer scales of 1-5, where the smaller the number the better the outcome. | Full Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Visit 4 (4-6 months) |
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| Secondary | Manifest Refraction | Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder. | Full Analysis Set | Posted | Mean | Standard Deviation | Diopters | Visit 3 (2-3 Months) | eyes | Participants |
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| Secondary | Manifest Refraction | Manifest refraction spherical equivalent (MRSE) was calculated as the value of the sphere plus one-half of the value of the cylinder. | Full Analysis Set | Posted | Mean | Standard Deviation | Diopters | Visit 4 (4-6 Months) | eyes | Participants |
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| Secondary | Uncorrected Distance Visual Acuity | High Contrast Uncorrected Distance (UCDVA) measured at 32 inches, Intermediate (UCIVA) at 32 inches, and Near Visual Acuity (UCNVA) at 16 inches | Full Analysis Set | Posted | Mean | Standard Deviation | logMAR | Visit 3 (2-3 months) Visit 4 (4-6 months) | eyes | Participants |
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| Secondary | Best-corrected Distance Visual Acuity | High Contrast Distance-Corrected Distance,(BCDVA), Intermediate (DCIVA), and Near Visual Acuity (DCNVA) | Full Analysis Set | Posted | Mean | Standard Deviation | logMAR | Visit 3 (2-3 months) Visit 4 (4-6 months) | eyes | Participants |
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| 0 |
| 26 |
| 10 |
| 52 |
| EG001 | ReSTOR | Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally. ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days. | 1 | 25 | 13 | 50 |
| EG002 | Tecnis Multifocal IOL | Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally. Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days. | 3 | 23 | 4 | 46 |
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| Retinal vein occlusion | Eye disorders | MedDRA (12.0) | Systematic Assessment | Severe central retinal vein occlusion, remained unresolved at the end of the study. |
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| Pulmonary embolism | Vascular disorders | MedDRA (12.0) | Systematic Assessment | Severe ongoing pulmonary embolism at visit 3 |
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| Pyelonephritis | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment | moderate pyelonephritis which was resolved in 12 days |
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| Punctate Keratitis | Eye disorders | MedDRA (12.0) | Systematic Assessment |
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| Increased Intraocular Pressure (IOP) | Eye disorders | MedDRA (12.0) | Systematic Assessment |
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Not provided
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| 6 cycles/degree |
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| UCDVA Binocular Visit 3 |
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| UCDVA Binocular Visit 4 |
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| UCIVA Monocular Visit 3 |
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| UCIVA Monocular Visit 4 |
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| UCIVA Binocular Visit 3 |
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| UCIVA Binocular Visit 4 |
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| UCNVA Monocular Visit 3 |
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| UCNVA Monocular Visit 4 |
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| UCNVA Binocular Visit 3 |
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| UCNVA Binocular Visit 4 |
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| BCDVA Binocular Visit 3 |
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| BCDVA Binocular Visit 4 |
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| DCIVA Monocular Visit 3 |
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| DCIVA Monocular Visit 4 |
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| DCIVA Binocular Visit 3 |
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| DCIVA Binocular Visit 4 |
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| DCNVA Monocular Visit 3 |
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| DCNVA Monocular Visit 4 |
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| DCNVA Binocular Visit 3 |
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| DCNVA Binocular Visit 4 |
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