ANCORA: Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
Study Details
Study Description
Brief Summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Higher Cylinder Toric IOL Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group. |
Device: Higher Cylinder Toric IOL
Symfony Toric models ZXT300 and ZXT375 IOL
|
Active Comparator: Lower Cylinder Toric IOL Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group. |
Device: Lower Cylinder Toric IOL
Symfony Toric model ZXT150 IOL
|
Outcome Measures
Primary Outcome Measures
- Rate of bothersome visual symptoms [6 months]
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire. The unit of measure will be percent.
- Rate of difficulty with an activity due to the visual symptoms [6 months]
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire. The unit of measure will be percent.
Eligibility Criteria
Criteria
Inclusion Criteria:
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be at least 22 years old
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have cataracts in both eyes
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have a certain degree of astigmatism in at least one eye
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sign the written informed consent
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be willing and able to comply with examination procedures
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understand, read and write English to complete informed consent and questionnaires
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be available for study follow-up visits
Both eyes must qualify to be eligible to participate in the study
Exclusion Criteria:
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Currently participating in any other clinical study or have participated in a clinical study during the last 30 days
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Have a certain disease/illness such as poorly-controlled diabetes
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Have certain ocular conditions such as uncontrolled glaucoma
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Taking medication that may affect subject vision
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Have irregular corneal astigmatism
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Pregnant, plan to become pregnant during the study, or is breastfeeding
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Empire Eye & Laser Center | Bakersfield | California | United States | 93309 |
2 | Southern California Eye Physicians & Associates | Long Beach | California | United States | 90805 |
3 | Santa Monica Eye Medical Group | Santa Monica | California | United States | 90404 |
4 | Wolstan & Goldberg Eye Associates | Torrance | California | United States | 90505 |
5 | Florida Eye Microsurgical Institute, Inc. | Boynton Beach | Florida | United States | 33426 |
6 | The Eye Associates of Manatee | Bradenton | Florida | United States | 34209 |
7 | Levenson Eye Associates | Jacksonville | Florida | United States | 32204 |
8 | North Florida Eye Surgeons, LLC dba Florida Eye Specialist | Jacksonville | Florida | United States | 32256 |
9 | Center For Sight | Sarasota | Florida | United States | 34239 |
10 | Virdi Eye Clinic & Laser Vision Care | Rock Island | Illinois | United States | 61201 |
11 | Chesapeake Eye Care & Laser | Annapolis | Maryland | United States | 21401 |
12 | Oakland Ophthalmic Surgery | Birmingham | Michigan | United States | 48009 |
13 | Tekwani Vision Center | Saint Louis | Missouri | United States | 63128 |
14 | Northern New Jersey Eye Institute PA | South Orange | New Jersey | United States | 07079 |
15 | Ludwick Eye Center | Chambersburg | Pennsylvania | United States | 17201 |
16 | Carolina Cataract & Laser Center | Ladson | South Carolina | United States | 29456 |
17 | Vance Thompson Vision | Sioux Falls | South Dakota | United States | 57108 |
18 | Memphis Eye & Cataract Associates, PLLC | Memphis | Tennessee | United States | 38119 |
19 | Cornea Associates of Texas | Dallas | Texas | United States | 75231 |
20 | Texas Eye & Laser Center | Hurst | Texas | United States | 76054 |
21 | Focal Point Vision | San Antonio | Texas | United States | 78209 |
22 | Parkhurst NuVision | San Antonio | Texas | United States | 78229 |
23 | Clarus Eye Centre | Lacey | Washington | United States | 98503 |
Sponsors and Collaborators
- Johnson & Johnson Surgical Vision, Inc.
Investigators
- Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TIOL-205-STPA