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

Primary Purpose

Cataract

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT
Sponsored by
Johnson & Johnson Surgical Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female at least 22 years of age
  2. Have a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation
  3. Regular corneal astigmatism that is planned for correction with an intraocular lens in the study eye(s)
  4. 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
  5. Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.

Exclusion Criteria:

  1. Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
  2. 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.
  3. Planned monovision correction (one eye designated for near correction)
  4. Severe or unstable systemic disease that may affect the heart, liver, kidney, lung, endocrine (including thyroid insufficiency), blood, or psychoneurological dysfunction

  5. Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study.

    -

Sites / Locations

  • Xiangya Hospital of Central South University
  • Guangzhou Aier Eye Hospital
  • Daqing Oil Field Central South University
  • Tianjin Medical University Eye Hospital
  • Shanghai Aier Eye Hospital
  • Shanxi Eye Hospital
  • Eye Hospital, Wenzhou Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Lens

Arm Description

TECNIS Multifocal Toric 1-piece lens, Model ZMT

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
June 29, 2021
Last Updated
October 9, 2023
Sponsor
Johnson & Johnson Surgical Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04954898
Brief Title
Post-market Evaluation of Clinical Outcomes in China for the TECNIS Model ZMT
Official Title
Post-market Evaluation of Clinical Outcomes in China for the TECNIS® Multifocal Toric 1-Piece Intraocular Lens Model Series ZMT
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Surgical Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Lens
Arm Type
Experimental
Arm Description
TECNIS Multifocal Toric 1-piece lens, Model ZMT
Intervention Type
Device
Intervention Name(s)
Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
The axis change is calculated as the absolute difference between intended IOL axis and the axis measured at follow-up visit(s).
Time Frame
1 day postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Surgical Vision Clinical Trials
Organizational Affiliation
Johnson & Johnson Surgical Vision
Official's Role
Study Director
Facility Information:
Facility Name
Xiangya Hospital of Central South University
City
Kaifu
State/Province
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Guangzhou Aier Eye Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Facility Name
Daqing Oil Field Central South University
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163000
Country
China
Facility Name
Tianjin Medical University Eye Hospital
City
Tianjin
State/Province
Nankai
ZIP/Postal Code
300384
Country
China
Facility Name
Shanghai Aier Eye Hospital
City
Xuhui
State/Province
Shanghai
ZIP/Postal Code
200336
Country
China
Facility Name
Shanxi Eye Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030072
Country
China
Facility Name
Eye Hospital, Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan 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
IPD Sharing URL
http://yoda.yale.edu

Learn more about this trial

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

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