Post-market Evaluation of Clinical Outcomes in China for... | NCT04954898

Studies
Post-market Evaluation of Clinical Outcomes in China for the TECNIS Model ZMT

NCT04954898

Sponsor

Johnson & Johnson Surgical Vision, Inc.

Status

Completed

Last Update Posted

May 23, 2025Actual

Enrollment

102Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 11, 2021Actual

Primary Completion Date

Jan 10, 2024Actual

Completion Date

Jan 10, 2024Actual

First Submitted Date

Jun 29, 2021

First Submission Date that Met QC Criteria

Jun 29, 2021

First Posted Date

Jul 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2025

Last Update Posted Date

May 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Lens	Experimental	TECNIS Multifocal Toric 1-piece lens, Model ZMT	Device: Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).	1 day postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Johnson & Johnson Surgical Vision Clinical Trials	Johnson & Johnson Surgical Vision	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Xiangya Hospital of Central South University		Kaifu	Changsha	410008	China
Guangzhou Aier Eye Hospital

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

http://yoda.yale.edu

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases