Post-Approval Study of the TECNIS SYMFONY® Toric Lenses (ANCORA)
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| ClinicalTrials.gov Identifier: NCT03791619 |
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Recruitment Status :
Completed
First Posted : January 2, 2019
Last Update Posted : September 7, 2022
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Sponsor:
Johnson & Johnson Surgical Vision, Inc.
Information provided by (Responsible Party):
Johnson & Johnson Surgical Vision, Inc.
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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 |
|---|---|---|
| Cataract Corneal Astigmatism | Device: Higher Cylinder Toric IOL Device: Lower Cylinder Toric IOL | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 473 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Post-Approval Study of the TECNIS SYMFONY® Toric Lenses |
| Actual Study Start Date : | December 13, 2018 |
| Actual Primary Completion Date : | August 8, 2022 |
| Actual Study Completion Date : | August 8, 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Device: Higher Cylinder Toric IOL
Symfony Toric models ZXT300 and ZXT375 IOL |
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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.
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Device: Lower Cylinder Toric IOL
Symfony Toric model ZXT150 IOL |
Primary Outcome Measures :
- Rate of bothersome visual symptoms [ Time Frame: 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 [ Time Frame: 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- be at least 22 years old
- have cataracts in both eyes
- have a certain degree of astigmatism in at least one eye
- sign the written informed consent
- be willing and able to comply with examination procedures
- understand, read and write English to complete informed consent and questionnaires
- be available for study follow-up visits
Both eyes must qualify to be eligible to participate in the study
Exclusion Criteria:
- Currently participating in any other clinical study or have participated in a clinical study during the last 30 days
- Have a certain disease/illness such as poorly-controlled diabetes
- Have certain ocular conditions such as uncontrolled glaucoma
- Taking medication that may affect subject vision
- Have irregular corneal astigmatism
- Pregnant, plan to become pregnant during the study, or is breastfeeding
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791619
Locations
Show 23 study locations
Sponsors and Collaborators
Johnson & Johnson Surgical Vision, Inc.
Investigators
| Study Director: | Johnson & Johnson Surgical Vision Clinical Trials | Johnson & Johnson Surgical Vision |
| Responsible Party: | Johnson & Johnson Surgical Vision, Inc. |
| ClinicalTrials.gov Identifier: | NCT03791619 |
| Other Study ID Numbers: |
TIOL-205-STPA |
| First Posted: | January 2, 2019 Key Record Dates |
| Last Update Posted: | September 7, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
Additional relevant MeSH terms:
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Cataract Astigmatism Lens Diseases Eye Diseases Refractive Errors |