CataractNCT04954898
Post-market Evaluation of Clinical Outcomes in China for the TECNIS Model ZMT
A study testing Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT in people with Cataract, run by Johnson & Johnson Surgical Vision, Inc. at 7 sites in China.
Trial summary
This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Multifocal Toric 1-Piece IOL. The study will enroll up to 120 subjects from up to 8 sites in China. The subjects will be followed for 12-months postoperatively. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 7 sitesChina
- Study dates
- 11 Aug 2021to 10 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male or female at least 22 years of age
- Have a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation
- Regular corneal astigmatism that is planned for correction with an 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 that are required by the study protocol
- Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.
Who cannot join
- Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
- Ocular disease (other than cataract) that may significantly affect postoperative vision, such as visually significant keratopathy, macular lesions, diabetic retinopathy, chronic or severe uveitis, etc.
- Planned monovision correction (one eye designated for near correction)
- Severe or unstable systemic disease that may affect the heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, or psychoneurological dysfunction
- Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study.
- -
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Daqing Oil Field Central South University
Daqing, Heilongjiang, 163000
Guangzhou Aier Eye Hospital
Guangzhou, Guangdong, 510010
Xiangya Hospital of Central South University
Kaifu, Changsha, 410008
Shanxi Eye Hospital
Taiyuan, Shanxi, 030072
Tianjin Medical University Eye Hospital
Tianjin, Nankai, 300384
Eye Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, 325027
Shanghai Aier Eye Hospital
Xuhui, Shanghai Municipality, 200336
About this study
Official title: Post-market Evaluation of Clinical Outcomes in China for the TECNIS® Multifocal Toric 1-Piece Intraocular Lens Model Series ZMT
This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Multifocal Toric 1-Piece IOL. The study will enroll up to 120 subjects from up to 8 sites in China. The subjects will be followed for 12-months postoperatively.
- Conditions
- Cataract
- Being tested
- Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMTDevice
Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with TECNIS Multifocal Toric 1-Piece IOL.
| Study group | Role | What they receive |
|---|---|---|
| Study Lens | Experimental | TECNIS Multifocal Toric 1-piece lens, Model ZMT Receives: Device: Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of eyes that are measured at the 1-day postoperative visit to demonstrate ≤10º change from The intended IOL axis at the end of surgery.
The axis change is calculated as the absolute difference between intended IOL axis and the axis measured at follow-up visit(s).
Measured: 1 day postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start11 Aug 2021
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 102 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
- NCT04954898
- Sponsor's protocol ID
- DIOL-301-CZMT
- Status last verified
- May 2025
- First submitted
- 29 Jun 2021
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Evaluation of Clinical Outcomes in China for the TECNIS® Multifocal Toric 1-Piece Intraocular Lens Model Series ZMT
- ClinicalTrials.gov ID
- NCT04954898
- Acronym / sponsor ID
- DIOL-301-CZMT
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
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 Multifocal Toric 1-Piece IOL. The study will enroll up to 120 subjects from up to 8 sites in China. The subjects will be followed for 12-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 |
|---|---|---|
| Study Lens | Experimental | Device: Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMTTECNIS Multifocal Toric 1-piece lens, Model ZMT |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female at least 22 years of age
- Have a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation
- Regular corneal astigmatism that is planned for correction with an 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 that are required by the study protocol
- Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.
Key exclusion criteria (6 listed)
- Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
- Ocular disease (other than cataract) that may significantly affect postoperative vision, such as visually significant keratopathy, macular lesions, diabetic retinopathy, chronic or severe uveitis, etc.
- Planned monovision correction (one eye designated for near correction)
- Severe or unstable systemic disease that may affect the heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, or psychoneurological dysfunction
- Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for 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 |
|---|---|---|
| Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMTSurgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with TECNIS Multifocal Toric 1-Piece IOL. | Device | Study Lens |
Primary outcome
The percentage of eyes that are measured at the 1-day postoperative visit to demonstrate ≤10º change from The intended IOL axis at the end of surgery.
Time frame: 1 day postoperative
The axis change is calculated as the absolute difference between intended IOL axis and the axis measured at follow-up visit(s).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- 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 Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT in people with Cataract, run by Johnson & Johnson Surgical Vision, Inc. at 7 sites in China.
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 5 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 23 May 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The percentage of eyes that are measured at the 1-day postoperative visit to demonstrate ≤10º change from The intended IOL axis at the end of surgery. (time frame: 1 day 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 23 May 2025.