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

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: Device: Model ICB00

• Registration Number: NCT05090813
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-12
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-25
• Study Start: 2021-12-24
• Primary Completion: 2024-04-22
• Study Completion: 2024-04-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Male or female patients at least 22 years of age
2. 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
3. Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits
4. 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. Planned monovision correction (one eye designated for near correction).
3. 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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TECNIS Eyhance IOL	Model ICB00	Model ICB00

Primary Outcome Measures

Name	Time	Method
percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA	6 months
mean monocular postoperative DCIVA	6 months

Trial Locations

Locations (1)

Hainan Eye Optometry Eye Hospital Co., Ltd. No. 6; 🇨🇳 Qionghai, Hainan, China