Back to resultsA Real-World Study in China for the TECNIS Eyhance™ Intraocular Lens
Primary Purpose
Cataracts
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Model ICB00
Sponsored by
About this trial
This is an interventional treatment trial for Cataracts
Eligibility Criteria
Inclusion Criteria:
- Male or female patients at least 22 years of age
- Have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with TECNIS Eyhance intraocular lens
- Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits
- 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
- Planned monovision correction (one eye designated for near correction).
- 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.).
Sites / Locations
- Hainan Eye Optometry Eye Hospital Co., Ltd. No. 6
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TECNIS Eyhance IOL
Arm Description
Model ICB00
Outcomes
Primary Outcome Measures
mean monocular postoperative DCIVA
percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA
Secondary Outcome Measures
Full Information
NCT ID
NCT05090813
First Posted
October 12, 2021
Last Updated
October 9, 2023
Sponsor
Johnson & Johnson Surgical Vision, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05090813
Brief Title
A Real-World Study in China for the TECNIS Eyhance™ Intraocular Lens
Official Title
A Real-World Study Evaluating Clinical Outcomes in China for the TECNIS Eyhance™ Intraocular Lens Model ICB00
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 24, 2021 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (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 and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Eyhance™ IOL. The study will enroll up to 100 subjects from a single site in China. All 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
Cataracts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TECNIS Eyhance IOL
Arm Type
Experimental
Arm Description
Model ICB00
Intervention Type
Device
Intervention Name(s)
Model ICB00
Intervention Description
Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes.
Primary Outcome Measure Information:
Title
mean monocular postoperative DCIVA
Time Frame
6 months
Title
percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients at least 22 years of age
Have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with TECNIS Eyhance intraocular lens
Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits
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
Planned monovision correction (one eye designated for near correction).
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.).
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
Hainan Eye Optometry Eye Hospital Co., Ltd. No. 6
City
Qionghai
State/Province
Hainan
ZIP/Postal Code
571434
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
A Real-World Study in China for the TECNIS Eyhance™ Intraocular Lens
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