CataractNCT04210232

Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL

A study testing TECNIS® TORIC II Intraocular Lens (IOL) in people with Cataract and Corneal Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites. 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?: TECNIS® TORIC II Intraocular Lens (IOL)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 12 sitesUnited States
Study dates: 14 Jan 2020to 11 Sep 2020
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

Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation have been planned;
Preoperative corneal astigmatism of one diopter or more in the operative eye;
Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 Snellen or better;
Clear intraocular media other than cataract in each eye;
Ability to understand, read and write English in order to consent to study participation;
Availability, willingness, sufficient cognitive awareness to comply with examination procedures;
Signed Informed Consent Document (ICD) and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Who cannot join

Recurrent severe anterior or posterior segment inflammation or uveitis;
Compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible;
Circumstances that would result in damage to the endothelium during implantation;
Suspected ocular microbial infection;
Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;
Known ocular disease or pathology that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, [macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.];
Planned monovision correction;
Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Chesapeake Eye Care and Laser Center
Annapolis, Maryland, 21401
Empire Eye & Laser Center
Bakersfield, California, 93309
Oakland Ophthalmic Surgery, P.C.
Birmingham, Michigan, 48009
Eye Doctors of Washington
Chevy Chase, Maryland, 20815
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Key & Whitman Eye Center
Dallas, Texas, 75243
Texas Eye and Laser Center
Hurst, Texas, 76054
Clarus Eye Center
Lacey, Washington, 98503
Carolina Cataract & Laser Center
Ladson, South Carolina, 29456
Parkhurst NuVision
San Antonio, Texas, 78229
Jones Eye Clinic
Sioux City, Iowa, 51104
Tekwani Vision Center
St Louis, Missouri, 63109

Other trials in United States

About this study

Official title: Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)

Conditions: Cataract, Corneal Astigmatism
Being tested: TECNIS® TORIC II Intraocular Lens (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.

TECNIS® TORIC II Intraocular Lens (IOL)Device
Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses.

Study groups in NCT04210232
Study group	Role	What they receive
TECNIS® TORIC II Intraocular Lens (IOL)	Experimental	Subjects will be implanted with the TECNIS Toric II IOL in one or both eyes qualified for study inclusion Receives: Device: TECNIS® TORIC II Intraocular Lens (IOL)

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II
Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).
Measured: 3 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 202011 Sep 2020

First posted24 Dec 2019
Study start14 Jan 2020
Primary completion11 Sep 2020
Study completion11 Sep 2020

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04210232
Sponsor's protocol ID: NXGT-201-TTL2
Status last verified: Oct 2021
First submitted: 23 Dec 2019
Last updated: 12 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)
ClinicalTrials.gov ID: NCT04210232
Acronym / sponsor ID: NXGT-201-TTL2
Conditions: Cataract, Corneal Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
Study start: 14 Jan 2020 (actual)
Primary completion: 11 Sep 2020 (actual)
Study completion: 11 Sep 2020 (actual)
First posted: 24 Dec 2019 (actual)
Results: Posted 12 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TECNIS® TORIC II Intraocular Lens (IOL)	Experimental	Device: TECNIS® TORIC II Intraocular Lens (IOL)Subjects will be implanted with the TECNIS Toric II IOL in one or both eyes qualified for study inclusion

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation have been planned;
Preoperative corneal astigmatism of one diopter or more in the operative eye;
Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 Snellen or better;
Clear intraocular media other than cataract in each eye;
Ability to understand, read and write English in order to consent to study participation;

Key exclusion criteria (8 listed)

Recurrent severe anterior or posterior segment inflammation or uveitis;
Compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible;
Circumstances that would result in damage to the endothelium during implantation;
Suspected ocular microbial infection;
Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;

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
TECNIS® TORIC II Intraocular Lens (IOL)Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses.	Device	TECNIS® TORIC II Intraocular Lens (IOL)

Primary outcome

Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II
Time frame: 3 months postoperative
Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).

Results and safety

Results posted to the registry on 12 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TECNIS Toric II	54	54

Primary outcome: Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II

Time frame: 3 months postoperative. Number (95% Confidence Interval). Unit: Percentage of eyes

Measure	TECNIS Toric II n = 53
Very Satisfied/Satisfied	100 (95.8 to 100)
Undecided/Dissatisfied/Very Dissatisfied	0 (0 to 4.2)

Population analysed: All Toric II Eyes

Adverse events

Time frame: 3 months postoperative. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TECNIS Toric II	6 of 54 (11.1%)	0 of 54 (0%)	0 of 54

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu

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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

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TECNIS® TORIC II Intraocular Lens (IOL) in people with Cataract and Corneal Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 12 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 7 inclusion and 8 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 12 Oct 2021). 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?

Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II (time frame: 3 months postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04210232.

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 12 Oct 2021.