CataractNCT05396599
A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens.
A study testing Model DIU, Model DFW and Model ZCT in people with Cataract, run by Johnson & Johnson Surgical Vision, Inc. at 5 sites in United States.
Trial summary
This is a prospective, multi-center, masked, three-arm, randomized clinical study of the TECNIS Eyhance Toric II IOL (test #1) and TECNIS Synergy Toric II (test #2) compared to the TECNIS Toric 1-Piece IOL (control). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Model DIU, Model DFW and Model ZCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jun 2022to 7 Apr 2023
- 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
- Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes:
- Male or female at least 22 years of age
- Have a cataract in one or both eyes, with planned phacoemulsification and intraocular lens implantation with a toric intraocular lens
- Regular corneal astigmatism and predicted postoperative residual astigmatism of less than 1.00 D after implantation with a toric intraocular lens in the study eye(s)
- Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with postoperative visits
- Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.
Who cannot join
- Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes:
- Best-corrected distance visual acuity better than 20/40 Snellen (0.3 logMAR)
- Potential visual acuity estimated to be worse than 20/32 Snellen (0.2 logMAR)
- Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
- Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) or unable to dilate to visualize IOL axis (approximately 6.0 mm)
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- Inability to achieve keratometric stability for contact lens wearers (as defined in Section 10.3 Preoperative Procedures)
- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
- Use of systemic or ocular medications that may affect vision
- Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) 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)
- Poorly controlled diabetes
- Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
- Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation that could lead to refractive changes
- Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
- Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Aloha Vision Consultants
Honolulu, Hawaii, 96817
Shultz Chang Vision
Los Angeles, California, 91325
Coastal Vision
Orange, California, 92868
Parkhurst NuVision
San Antonio, Texas, 78229
Pacific Eye Associates, A Medical Corporation
San Francisco, California, 94115
About this study
This is a prospective, multi-center, masked, three-arm, randomized clinical study of the TECNIS Eyhance Toric II IOL (test #1) and TECNIS Synergy Toric II (test #2) compared to the TECNIS Toric 1-Piece IOL (control).
- Conditions
- Cataract
- Being tested
- Model DIU, Model DFW, Model ZCT
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model DIUDevice
Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
Model DFWDevice
Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
Model ZCTDevice
Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
| Study group | Role | What they receive |
|---|---|---|
| Eyhance Toric II IOL | Experimental | Model DIU Receives: Device: Model DIU |
| TECNIS Synergy Toric II | Experimental | Model DFW Receives: Device: Model DFW |
| TECNIS Toric 1-Piece IOL | Active comparator | Model ZCT Receives: Device: Model ZCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational Stability of IOL
The percentage of eyes with rotational stability of the IOL at postoperative 1 month.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start30 Jun 2022
- Primary completion7 Apr 2023
- Study completion7 Apr 2023
Why it stopped: Business Decision.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 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, Inc. Clinical Trial, Study director, Johnson & Johnson Surgical Vision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396599
- Sponsor's protocol ID
- JJSV201EYST
- Status last verified
- May 2024
- First submitted
- 25 May 2022
- Last updated
- 4 Jun 2024
- 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens.
- ClinicalTrials.gov ID
- NCT05396599
- Acronym / sponsor ID
- JJSV201EYST
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Posted 4 Jun 2024
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, multi-center, masked, three-arm, randomized clinical study of the TECNIS Eyhance Toric II IOL (test #1) and TECNIS Synergy Toric II (test #2) compared to the TECNIS Toric 1-Piece IOL (control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eyhance Toric II IOL | Experimental | Device: Model DIUModel DIU |
| TECNIS Synergy Toric II | Experimental | Device: Model DFWModel DFW |
| TECNIS Toric 1-Piece IOL | Active comparator | Device: Model ZCTModel ZCT |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes:
- Male or female at least 22 years of age
- Have a cataract in one or both eyes, with planned phacoemulsification and intraocular lens implantation with a toric intraocular lens
- Regular corneal astigmatism and predicted postoperative residual astigmatism of less than 1.00 D after implantation with a toric intraocular lens in the study eye(s)
- Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with postoperative visits
Key exclusion criteria (15 listed)
- Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes:
- Best-corrected distance visual acuity better than 20/40 Snellen (0.3 logMAR)
- Potential visual acuity estimated to be worse than 20/32 Snellen (0.2 logMAR)
- Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
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 |
|---|---|---|
| Model DIUSubjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted. | Device | Eyhance Toric II IOL |
| Model DFWSubjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted. | Device | TECNIS Synergy Toric II |
| Model ZCTSubjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted. | Device | TECNIS Toric 1-Piece IOL |
Primary outcome
Rotational Stability of IOL
Time frame: 1 month
The percentage of eyes with rotational stability of the IOL at postoperative 1 month.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- 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, Inc. Clinical Trial study director
Johnson & Johnson Surgical Vision, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Model DIU, Model DFW and Model ZCT in people with Cataract, run by Johnson & Johnson Surgical Vision, Inc. at 5 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 4 Jun 2024). 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?
Rotational Stability of IOL (time frame: 1 month). 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 4 Jun 2024.