CataractSTEELENCT04327518
Evaluation of the Rotational Stability of the Tecnis Toric II IOL
A study testing TECNIS® Toric II in people with Cataract and Corneal Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 7 sites in United States.
Trial summary
This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Jun 2020to 1 Jun 2021
- 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
- Minimum 22 years of age;
- Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned;
- Pre-existing corneal astigmatism of one diopter or greater;
- Predicted residual refractive cylinder based on toric IOL calculator, considering surgically induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be ≤0.50 D;
- Potential for postoperative BCDVA of 20/30 Snellen or better;
- Clear intraocular media other than cataract in each eye;
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- Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits;
- Signed informed consent form (ICF) and health insurance portability and accountability act (HIPAA) authorization;
- Ability to understand and respond to a questionnaire in English.
Who cannot join
- Irregular corneal astigmatism;
- Any corneal pathology/abnormality other than regular corneal astigmatism or corneal instability due to contact lens wear;
- Previous corneal or intraocular surgery;
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
- Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils);
- Dilated pupil size of < 6.0 mm;
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- Recurrent severe anterior or posterior segment inflammation or uveitis;
- 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 or systemic disease 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.];
- Use of systemic or ocular medications (e.g., Flomax) that may affect vision including prior, current, or anticipated use during the course of the study that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);
- Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes;
- Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.
- Planned monovision correction (eye designated for near correction)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Empire Eye and Laser Center, Inc.
Bakersfield, California, 93309
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
JW Eye Associates, P.A. DBA Key-Whitman Eye Center
Dallas, Texas, 75243
Texas Eye & Laser Center, P.A.
Hurst, Texas, 76054
University of California
Los Angeles, California, 92705
Jones Eye Clinic
Sioux City, Iowa, 51104
Vance Thompson Vision, ND
West Fargo, North Dakota, 58078
About this study
Official title: Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens
This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.
- Conditions
- Cataract, Corneal Astigmatism
- Being tested
- TECNIS® Toric II
- 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 IIDevice
Toric Intraocular Lens
| Study group | Role | What they receive |
|---|---|---|
| TECNIS® Toric II | Experimental | Subjects will be implanted in one or both eyes with the study lens Receives: Device: TECNIS® Toric II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit
Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method.
Measured: 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start11 Jun 2020
- Primary completion6 Apr 2021
- Study completion1 Jun 2021
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
- 125 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
- NCT04327518
- Sponsor's protocol ID
- NXGT-202-QROS
- Acronym
- STEELE
- Status last verified
- May 2022
- First submitted
- 27 Mar 2020
- Last updated
- 1 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens
- ClinicalTrials.gov ID
- NCT04327518
- Acronym / sponsor ID
- STEELE / NXGT-202-QROS
- Conditions
- Cataract, Corneal Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 6 Apr 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Posted 1 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.
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 | Experimental | Device: TECNIS® Toric IISubjects will be implanted in one or both eyes with the study lens |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Minimum 22 years of age;
- Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned;
- Pre-existing corneal astigmatism of one diopter or greater;
- Predicted residual refractive cylinder based on toric IOL calculator, considering surgically induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be ≤0.50 D;
- Potential for postoperative BCDVA of 20/30 Snellen or better;
Key exclusion criteria (13 listed)
- Irregular corneal astigmatism;
- Any corneal pathology/abnormality other than regular corneal astigmatism or corneal instability due to contact lens wear;
- Previous corneal or intraocular surgery;
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
- Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils);
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 IIToric Intraocular Lens | Device | TECNIS® Toric II |
Primary outcome
Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit
Time frame: 1 week postoperative
Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- 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
7 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 in people with Cataract and Corneal Astigmatism, run by Johnson & Johnson Surgical Vision, Inc. at 7 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 9 inclusion and 13 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 1 Jun 2022). 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?
Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit (time frame: 1 week postoperative). 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 1 Jun 2022.