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OpenTrials
Completed

NCT Number: NCT06005675

User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL

Prospective collection of data from medical records, multicenter, post-market clinical follow-up study.

Completed

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previously bilaterally implanted with TECNIS Odyssey IOL, following cataract extraction;
  • Enrollment at least 21 days after second eye surgery;
  • Clear intraocular media in each eye;
  • Signed informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;
  • Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures;
  • Ability to understand, read, and write in English

Exclusion criteria

  • Concurrent participation in an interventional clinical trial during the time from which the data will be collected;
  • Use of systemic or ocular medication that may affect vision
  • Prior corneal refractive surgery in each eye (i.e., LASIK, PRK, SMILE, RK, CK); NOTE: Limbal relaxing incisions (LRI) are permissible as planned at the time of surgery (intraoperatively) but not postoperatively until after completion of the study visits;
  • Ongoing adverse events that might impact study measurements, as determined by the investigator;
  • Acute or chronic disease or condition, ocular trauma, or surgery that may confound study measurements (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus, etc.);
  • Amblyopia, strabismus, nystagmus in each eye

Treatment and study plan

Intervention

Device

No study treatments will be administered during this study.

Primary outcomes

  1. Visual Acuities

    Time frame: 1-month postoperative

    Visual Acuity will be collected via observed case data in units of logMAR.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2023
Registry last updated
Apr 25, 2025

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.

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