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

NCT06767319 | Completed

• 1 other identifier: MDEV110SDVA
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 4

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. 1.Trial lens method
2. 2.Chart testing at appropriate focal distances (or viewing distances)

Conditions

Depth of Focus

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (1)

Testing Order

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.

Other: No intervention

Interventions

No intervention OTHER

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.

Testing Order

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As only one eye per subject will be enrolled in the study based on the eligibility criteria, up to 115 subjects will be enrolled to obtain data on approximately 80 subjects to account for approximately 30% screen failure rate.

You may qualify if:

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

You may not qualify if:

• Patients within 30 days postoperative from surgery;
• BCDVA worse than 20/32;
• Posterior capsular opacification or other medical findings affecting best-corrected distance visual acuity (BCDVA) in the opinion of the investigator;
• Clinically significant ocular surface disease that would affect study measurements based on investigator medical opinion;
• Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);
• 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.);
• 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.

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (4)

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Jones Eye Center

Sioux City, Iowa, 51104, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 9, 2025
• Study Start: December 18, 2024
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (4)