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OpenTrials
Completed

NCT Number: NCT05991960

Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Assil Eye Institute, Beverly Hills, 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 consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.

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 within the retrospective analysis window;
  • Ongoing adverse events in each eye that might impact outcomes during the study visit as determined by the investigator;
  • Acute or chronic disease or condition, ocular trauma or surgery that may affect vision in each eye (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 retrospective study. However, data will be collected from medical records of patients who have been treated with the subject device of this study.

Primary outcomes

  1. Visual Acuity

    Time frame: 1-month postoperative

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

  2. Manifest Refraction

    Time frame: 1-month postoperative

    Manifest Refraction will be collected via observed case data in units of diopters.

  3. Visual Symptoms/Complaints

    Time frame: 1-month postoperative

    Visual Symptoms/Complaints will be measured using a questionnaire on a 5-point scale.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 15, 2023
Registry last updated
Feb 2, 2024

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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