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CataractsNCT05053399

Evaluation of the TECNIS Symfony® Toric Intraocular Lens

A study testing Model Series ZXT in people with Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 1 site in China.

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 prospective, single-center, single-arm, open-label, clinical study of the investigational TECNIS Symfony® Toric IOL. The study will enroll up to 100 subjects from a single investigative site in China. The subjects will be followed for 12-months postoperatively. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cataracts
What is being tested?
Model Series ZXT
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteChina
Study dates
24 Nov 2021to 30 Apr 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients at least 18 years of age
  • Have a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation
  • Have estimated postoperative visual acuity of at least 20/25 Snellen (0.8 decimal) in the eye to be implanted per surgeon estimate \
  • Regular corneal astigmatism and predicted postoperative residual astigmatism of less than 1.00 D after implantation with a toric intraocular 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.
  • Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs
  • Irregular corneal astigmatism
  • Inability to achieve keratometric stability for contact lens wearers (as defined in Section 10.3 Preoperative Procedures)
  • Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity loss to a level worse than 20/30 Snellen (0.67 decimal) during the study
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  • Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
  • Use of systemic or ocular medications that may affect vision, 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)
  • 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.
  • Planned monovision correction (one eye designated for near correction).
  • Patients who are pregnant or nursing.
  • 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, affect visual acuity or may require surgical intervention during the course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009

Other trials in China

About this study

Official title: Evaluation of Clinical Outcomes in China for the TECNIS Symfony® Toric Intraocular Lens Model Series ZXT

This is a prospective, single-center, single-arm, open-label, clinical study of the investigational TECNIS Symfony® Toric IOL. The study will enroll up to 100 subjects from a single investigative site in China. The subjects will be followed for 12-months postoperatively.

Conditions
Cataracts
Being tested
Model Series ZXT
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Model Series ZXTDevice

    Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

Study groups in NCT05053399
Study groupRoleWhat they receive
TECNIS Symfony Toric IOLExperimentalModel Series ZXT
Receives: Device: Model Series ZXT

What is being measured

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

  1. percentage of eyes that are measured at the 1-week postoperative visit to demonstrate ≤10º change from the intended IOL axis at the end of surgery

    Measured: 1 week

Timeline

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

  1. First posted22 Sep 2021
  2. Study start24 Nov 2021
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

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
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05053399
Sponsor's protocol ID
PCOL-202-CHSF
Status last verified
Jul 2025
First submitted
16 Sep 2021
Last updated
23 Jul 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

Questions about this trial

What is this clinical trial studying?

A study testing Model Series ZXT in people with Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 1 site 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 6 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

percentage of eyes that are measured at the 1-week postoperative visit to demonstrate ≤10º change from the intended IOL axis at the end of surgery (time frame: 1 week). 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 NCT05053399.

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 Jul 2025.

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