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

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05090813
• Other study ID #: EMON-201-CHEY
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 24, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Device:
• Model ICB00
Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes.

Locations

Country	Name	City	State
China	Hainan Eye Optometry Eye Hospital Co., Ltd. No. 6	Qionghai	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean monocular postoperative DCIVA		6 months
Primary	percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA		6 months