Prospective, Multi-center, Non-interventional, Open Label, Randomized (Depth of Focus Testing Sequences), Clinical Study

Completed

• Conditions: Depth of Focus

• Registration Number: NCT06767319
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

Brief Summary

The purpose of this clinical study is to evaluate the difference in depth of focus measured with two methods in patients implanted with either TECNIS 1-piece Monofocal IOL or TECNIS Eyhance IOL:

1. Trial lens method

2. Chart testing at appropriate focal distances (or viewing distances)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-17
• Study Start: 2024-12-18
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-09
• Primary Completion: 2025-03-11
• Study Completion: 2025-03-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

1. Patients unilaterally or bilaterally implanted with a TECNIS non-toric/toric monofocal or TECNIS non-toric/toric Eyhance IOL;
2. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws in U.S.;
3. Availability, willingness, and sufficient cognitive awareness to comply with examination procedures.
4. Adults (Minimum 22 years of age or older at the time of participation in the study);

Study Eye Exclusion Criteria

1. Patients within 30 days postoperative from surgery;
2. BCDVA worse than 20/32;
3. Posterior capsular opacification or other medical findings affecting best-corrected distance visual acuity (BCDVA) in the opinion of the investigator;
4. Clinically significant ocular surface disease that would affect study measurements based on investigator medical opinion;
5. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
6. Known ocular disease or pathology that, in the opinion of the investigator may affect visual acuity (macular degeneration, cystoid macular edema, diabetic retinopathy, glaucoma, retinal detachment etc.);
7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.	One day Visit study	The difference in diopters of depth of focus range achieving a threshold of 0.20 logMAR between Trial lens vs. Chart testing method per pre-study IOL group.

Trial Locations

Locations (4)

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

Parkhurst NuVision; 🇺🇸 San Antonio, Texas, United States

Empire Eye & Laser Center; 🇺🇸 Bakersfield, California, United States

Jones Eye Center; 🇺🇸 Sioux City, Iowa, United States