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

Comparison of Depth of Focus Testing Methods

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)

Study Overview

• Status: Completed
• Conditions: Depth of Focus
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye & Laser Center
  • Iowa
    • Sioux City, Iowa, United States, 51104
      • Jones Eye Center
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • Texas
    • San Antonio, Texas, United States, 78229
      • Parkhurst NuVision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Study Eye 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Actual): March 11, 2025
• Study Completion (Actual): March 11, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MDEV110SDVA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No