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

Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04954898
Collaborator
(none)
120
Enrollment
1
Location
1
Arm
14.7
Anticipated Duration (Months)
8.2
Patients Per Site Per Month

Study Details

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 5 sites in China. The subjects will be followed for 12-months postoperatively.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Post-market Evaluation of Clinical Outcomes in China for the TECNIS® Multifocal Toric 1-Piece Intraocular Lens Model Series ZMT
Actual Study Start Date :
Aug 11, 2021
Anticipated Primary Completion Date :
Nov 15, 2021
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Study Lens

TECNIS Multifocal Toric 1-piece lens, Model ZMT

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

Outcome Measures

Primary Outcome Measures

  1. 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. [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Eye Hospital, Wenzhou Medical UniversityWenzhouZhejiangChina325027

Sponsors and Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

Investigators

  • Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT04954898
Other Study ID Numbers:
  • DIOL-301-CZMT
First Posted:
Jul 8, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2021