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OpenTrials
Completed

NCT Number: NCT06767319

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

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)

Completed

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Key information

Conditions

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Empire Eye & Laser Center, Bakersfield, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Study Eye Inclusion Criteria:

  • 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);

Study Eye Exclusion Criteria

  • 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.

Treatment and study plan

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.

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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Official study title

Comparison of Depth of Focus Testing Methods

Acronym: Sierra

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.