A Real-World Study in China for the TECNIS Eyhance™ Intraocular Lens

NCT05090813 | Completed

• 1 other identifier: EMON-201-CHEY
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataracts

Outcome Measures

Primary Outcomes (2)

• mean monocular postoperative DCIVA

  6 months

• percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA

  6 months

Study Arms (1)

TECNIS Eyhance IOL

EXPERIMENTAL

Model ICB00

Device: Model ICB00

Interventions

Model ICB00 DEVICE

Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes.

TECNIS Eyhance IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (1)

Hainan Eye Optometry Eye Hospital Co., Ltd. No. 6

Qionghai, Hainan, 571434, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Johnson & Johnson Surgical Vision Clinical Trials

  Johnson & Johnson Surgical Vision

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: December 24, 2021
• Primary Completion: April 22, 2024
• Study Completion: April 22, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)