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The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 | Experimental | Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00 |
|
| TECNIS Monofocal IOL, Model ZCB00 | Active Comparator | Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 | Device |
| ||
| TECNIS Monofocal IOL, Model ZCB00 |
| Measure | Description | Time Frame |
|---|---|---|
| Distance Corrected Intermediate Visual Acuity | FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity. | At 6 months |
| Uncorrected Intermediate Visual Acuity | Uncorrected Intermediate Visual Acuity at 6 months. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boozman-Hof Regional Eye Clinic | Rogers | Arkansas | 72756 | United States | ||
| Empire Eye & Laser Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34269326 | Derived | Chang DH, Janakiraman DP, Smith PJ, Buteyn A, Domingo J, Jones JJ, Christie WC. Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial. J Cataract Refract Surg. 2022 Mar 1;48(3):288-297. doi: 10.1097/j.jcrs.0000000000000747. |
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A total of 23 subjects were consented but were not assigned to a group due to failure to meet inclusion/exclusion criteria, withdrawn consent, non-ocular health, or lost-to-follow-up.
Beginning August 27, 2014, a total of 324 subjects were enrolled (consented) in the study and 299 of these subjects were implanted with a study lens in at least one operative eye between September 16, 2014, and February 10, 2015, across 15 U.S. clinical sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | TECNIS Intraocular Lens, Model ZXR00 | Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00 |
| FG001 | TECNIS Intraocular Lens, Model ZCB00 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Device |
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| Bakersfield |
| California |
| 93309 |
| United States |
| Katzen Eye Care & Laser Center | Boynton Beach | Florida | 33426 | United States |
| Cape Coral Eye 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 |
| Jones Eye Clinic | Sioux City | Iowa | 51104 | United States |
| Eye Doctors of Washington | Chevy Chase | Maryland | 20815 | 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 |
| Loden Vision Center | Goodlettsville | Tennessee | 37072 | United States |
| Whitsett Vision Group | Houston | Texas | 77055 | United States |
| Texas Eye and Laser Center | Hurst | Texas | 76054 | United States |
| Lehmann Eye Center | Nacogdoches | Texas | 75965 | United States |
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TECNIS Intraocular Lens, Model ZXR00 | Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00 |
| BG001 | TECNIS Intraocular Lens, Model ZCB00 | Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00 |
| BG002 | 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Gender | Count of Participants | Participants |
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| 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 | Distance Corrected Intermediate Visual Acuity | FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity. | Intent to Treat Population | Posted | Mean | Standard Error | LogMAR | At 6 months |
|
|
| ||||||||||||||||||||||||||||
| Primary | Uncorrected Intermediate Visual Acuity | Uncorrected Intermediate Visual Acuity at 6 months. | Intent to Treat population | Posted | Mean | Standard Error | LogMAR | 6 months |
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|
6 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 Intraocular Lens, Model ZXR00 | Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00 | 5 | 148 | 0 | 148 | ||
| EG001 | TECNIS Intraocular Lens, Model ZCB00 | Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00 | 11 | 151 | 0 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid Macular Edema | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Pupillary Capture | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Endophthalmitis | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Hypopyon | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Epiretinal Membrane Peel | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Anterior Ischemic Optic Neuropathy | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Lens Fragment | Eye disorders | MedDRA (17.0) | Systematic Assessment | Requiring fragment removal |
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| Anterior Basement Membrane Distrophy | Eye disorders | MedDRA (17.0) | Systematic Assessment |
| |
| Inflammation | Eye disorders | MedDRA (17.0) | Systematic Assessment | Requiring treatment injection |
|
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kendra Hileman, Ph.D., Director of Clinical Research and Development | Abbott Medical Optics | 714-247-8613 | kendra.hileman@abbott.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| >=65 years |
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| Male |
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