CataractANCORANCT03791619
Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
A study testing Higher Cylinder Toric IOL and Lower Cylinder Toric IOL in people with Cataract and Corneal Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract, Corneal Astigmatism
- What is being tested?
- Higher Cylinder Toric IOL and Lower Cylinder Toric IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 23 sitesUnited States
- Study dates
- 13 Dec 2018to 8 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Chesapeake Eye Care & Laser
Annapolis, Maryland, 21401
Empire Eye & Laser Center
Bakersfield, California, 93309
Oakland Ophthalmic Surgery
Birmingham, Michigan, 48009
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426
The Eye Associates of Manatee
Bradenton, Florida, 34209
Ludwick Eye Center
Chambersburg, Pennsylvania, 17201
Cornea Associates of Texas
Dallas, Texas, 75231
Texas Eye & Laser Center
Hurst, Texas, 76054
Levenson Eye Associates
Jacksonville, Florida, 32204
North Florida Eye Surgeons, LLC dba Florida Eye Specialist
Jacksonville, Florida, 32256
Clarus Eye Centre
Lacey, Washington, 98503
Carolina Cataract & Laser Center
Ladson, South Carolina, 29456
Southern California Eye Physicians & Associates
Long Beach, California, 90805
Memphis Eye & Cataract Associates, PLLC
Memphis, Tennessee, 38119
Virdi Eye Clinic & Laser Vision Care
Rock Island, Illinois, 61201
Focal Point Vision
San Antonio, Texas, 78209
Parkhurst NuVision
San Antonio, Texas, 78229
Santa Monica Eye Medical Group
Santa Monica, California, 90404
Center For Sight
Sarasota, Florida, 34239
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Northern New Jersey Eye Institute PA
South Orange, New Jersey, 07079
Tekwani Vision Center
St Louis, Missouri, 63128
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
About this study
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.
- Conditions
- Cataract, Corneal Astigmatism
- Being tested
- Higher Cylinder Toric IOL, Lower Cylinder Toric IOL
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher Cylinder Toric IOLDevice
Symfony Toric models ZXT300 and ZXT375 IOL
Lower Cylinder Toric IOLDevice
Symfony Toric model ZXT150 IOL
| Study group | Role | What they receive |
|---|---|---|
| Higher Cylinder Toric IOL | Active comparator | 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. Receives: Device: Higher Cylinder Toric IOL |
| Lower Cylinder Toric IOL | Active comparator | 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. Receives: Device: Lower Cylinder Toric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Bothersome Visual Symptoms
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
Measured: 6-month
Rate of Difficulty With an Activity Due to the Visual Symptoms
The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start13 Dec 2018
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Surgical Vision Clinical Trials, Study director, Johnson & Johnson Surgical Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791619
- Sponsor's protocol ID
- TIOL-205-STPA
- Acronym
- ANCORA
- Status last verified
- Aug 2023
- First submitted
- 11 Dec 2018
- Last updated
- 29 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
- ClinicalTrials.gov ID
- NCT03791619
- Acronym / sponsor ID
- ANCORA / TIOL-205-STPA
- Conditions
- Cataract, Corneal Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Posted 29 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher Cylinder Toric IOL | Active comparator | Device: Higher Cylinder Toric IOLConsented 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. |
| Lower Cylinder Toric IOL | Active comparator | Device: Lower Cylinder Toric IOLConsented 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Higher Cylinder Toric IOLSymfony Toric models ZXT300 and ZXT375 IOL | Device | Higher Cylinder Toric IOL |
| Lower Cylinder Toric IOLSymfony Toric model ZXT150 IOL | Device | Lower Cylinder Toric IOL |
Primary outcome
Rate of Bothersome Visual Symptoms
Time frame: 6-month
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
Rate of Difficulty With an Activity Due to the Visual Symptoms
Time frame: 6-month
The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Surgical Vision Clinical Trials study director
Johnson & Johnson Surgical Vision
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Higher Cylinder Toric IOL and Lower Cylinder Toric IOL in people with Cataract and Corneal Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Bothersome Visual Symptoms (time frame: 6-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.