A Real-World Study Evaluating Clinical Outcomes in China for the TECNIS Eyhance™ Intraocular Lens Model ICB00

Johnson & Johnson Surgical Vision, Inc.1 site in 1 country24 target enrollmentDecember 24, 2021

ConditionsCataracts

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataracts
Sponsor: Johnson & Johnson Surgical Vision, Inc.
Enrollment: 24
Locations: 1
Primary Endpoint: percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 24, 2021

End Date

April 22, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Johnson & Johnson Surgical Vision, Inc.

Responsible Party

Sponsor

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.).