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The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecnis Multifocal Intraocular lens #1 | Experimental | A low diopter add multifocal intraocular lens |
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| Tecnis Multifocal Intraocular Lens #2 | Experimental | A low diopter add multifocal intraocular lens |
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| Monofocal Intraocular Lens | Active Comparator | Commercially available monofocal intraocular lens (IOL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecnis Multifocal Intraocular Lens | Device |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm | Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Diopter Range With VA of 20/40 or Better | Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy. * The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kendra Hileman, PhD | Abbott Medical Optics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fishkind, Bakewell & Maltzman Eye Care & Surgery Center | Tucson | Arizona | 85704 | United States | ||
| Boozman-Hof Regional Eye Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tecnis Multifocal Intraocular Lens #1 | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens |
| FG001 | Tecnis Multifocal Intraocular Lens #2 | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Monofocal Intraocular Lens |
| Device |
|
| six months |
| Spectacle Independence | Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone. | six months |
| Rogers |
| Arkansas |
| 72757 |
| United States |
| Empire Eye & Laser Center | Bakersfield | California | 93309 | United States |
| Assil Eye Institute | Beverly Hills | California | 90210 | United States |
| Cape Coral Eye Center (Argus Research Center) | Cape Coral | Florida | 33904 | United States |
| Virdi Eye Clinic & Laser Vision Center | Rock Island | Illinois | 61201 | United States |
| Eye Surgeons of Indiana | Indianapolis | Indiana | 46256 | United States |
| Wallace Eye Surgery | Alexandria | Louisiana | 71303 | United States |
| Pepose Vision Institute | Chesterfield | Missouri | 63017 | United States |
| Ophthalmic Consultants of Long Island | Rockville Centre | New York | 11570 | United States |
| The Eye Center of Central PA | Allenwood | Pennsylvania | 17810 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Bucci Cataract & Laser Vision | Wilkes-Barre | Pennsylvania | 18702 | United States |
| Loden Vision Center | Goodlettsville | Tennessee | 37072 | United States |
| Whitsett Vision Group | Houston | Texas | 77055 | United States |
| Lone Star Eye Care | Sugar Land | Texas | 77479 | United States |
| Clarus Eye Centre | Lacey | Washington | 98503 | United States |
| The Midline Eye Institute | Solihull | B91 2AW | United Kingdom |
| FG002 | Monofocal Intraocular Lens | Commercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tecnis Multifocal Intraocular Lens #1 | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens |
| BG001 | Tecnis Multifocal Intraocular Lens #2 | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens |
| BG002 | Monofocal Intraocular Lens | Commercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age was grouped by catagories as described in the table. | Number | participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm | Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative | eyes | Posted | Mean | Standard Deviation | LogMAR VA | six months |
|
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| |||||||||||||||||||||||||||||||
| Secondary | Mean Diopter Range With VA of 20/40 or Better | Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy. * The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively. | eyes | Posted | Mean | Standard Deviation | diopters | six months |
| |||||||||||||||||||||||||||||||||
| Secondary | Spectacle Independence | Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone. | Five subjects (3 from Group #1 [145-142], 1 from Group #2 [150-149], and 1 from the monofocal control group [146-145]) did not complete the questionnaire because they were unavailable, refused to complete it, implant status precluded completion (bilateral implants required), or failed to answer this particular question. | Posted | Number | participants | six months |
|
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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 | Tecnis Multifocal Intraocular Lens #1 | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | 2 | 147 | 0 | 147 | ||
| EG001 | Tecnis Multifocal Intraocular Lens #2 | A low diopter add multifocal intraocular lens Tecnis Multifocal Intraocular Lens | 8 | 150 | 0 | 150 | ||
| EG002 | Monofocal Intraocular Lens | Commercially available monofocal intraocular lens (IOL) Monofocal Intraocular Lens | 3 | 148 | 0 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Secondary surgical intervention - not lens-related | Eye disorders | Systematic Assessment |
| ||
| Secondary surgical intervention - lens-related | Eye disorders | Systematic Assessment |
| ||
| Orbital fracture | Eye disorders | Systematic Assessment | Orbital fracture was attributed to a fall. Subject also sustained limbal wound rupture and iris prolapse. |
| |
| Central retinal artery occlusion | Eye disorders | Systematic Assessment |
| ||
| Endophthalmitis/hypopyon | Eye disorders | Systematic Assessment |
| ||
| Cystoid macular edema | Eye disorders | Systematic Assessment |
|
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After the trial is completed, investigators must obtain approval from AMO in writing prior to disclosing trial results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kendra Hileman, Ph.D., Director, Clinical Research & Development | Abbott Medical Optics | 714-247-8613 | kendra.hileman@amo.abbott.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 60 - 69 years |
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| 70 - 79 years |
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| Greater than or equal to 80 years |
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| Not reported |
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| Male |
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| United Kingdom |
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