CClinicalTrials.gg
CompletedNCT05991960Updated Feb 2, 2024

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

An observational study in Cataracts, sponsored by Johnson & Johnson Surgical Vision, Inc.. Completed at 12 sites in United States. Per ClinicalTrials.gov, last updated 2024-02-02.

Sponsored by Johnson & Johnson Surgical Vision, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
96
Sex
All
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Study summary

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

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Conditions studied

  • Cataracts

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 96 is above the median of 81 across 484 observational studies indexed under Cataract.

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Lead sponsor

Johnson & Johnson Surgical Vision, Inc. is the lead sponsor of 36 studies on the registry; 1 is open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 13 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pseudophakic patients previously bilaterally implanted with TECNIS Odyssey IOL.

Inclusion criteria

  1. Previously bilaterally implanted with TECNIS Odyssey IOL, following cataract extraction;
  2. Enrollment at least 21 days after second eye surgery;
  3. Clear intraocular media in each eye.
  4. Signed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.

Exclusion criteria

Exclusion Criteria:

  1. Concurrent participation in an interventional clinical trial during the time from which the data will be collected;
  2. Use of systemic or ocular medication that may affect vision;
  3. 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;
  4. Ongoing adverse events in each eye that might impact outcomes during the study visit as determined by the investigator;
  5. 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.).
  6. Amblyopia, strabismus, nystagmus in each eye.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
96 participants (actual)
Patient registry
No

Interventions

  • DeviceIntervention

    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.

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What researchers measure

Primary outcomes

  1. Visual Acuity

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

    Time frame: 1-month postoperative

  2. Manifest Refraction

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

    Time frame: 1-month postoperative

  3. Visual Symptoms/Complaints

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

    Time frame: 1-month postoperative

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Study locations

12 sites
  • Assil Eye Institute
    Beverly Hills, California 90210, United States
  • The Eye Institute of West Florida
    Largo, Florida 33770, United States
  • Center for Sight
    Sarasota, Florida 34239, United States
  • Aloha Vision Consultants
    Honolulu, Hawaii 96816, United States
  • OCLI Vision
    Garden City, New York 11530, United States
  • Vance Thompson Vision
    W. Fargo, North Dakota 58078, United States
  • Cleveland Eye Clinic
    Brecksville, Ohio 44141, United States
  • Carolina EyeCare Physicians
    Mount Pleasant, South Carolina 29464, United States
  • Loden Vision Centers
    Goodlettsville, Tennessee 37072, United States
  • Dell Laser Consultants
    Austin, Texas 78746, United States
  • Whitsett Vision Group
    Houston, Texas 77055, United States
  • Virginia Eye Consultants
    Norfolk, Virginia 23502, United States
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References and documents

Individual participant data

Plan to share: Yes — Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) 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

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05991960
Lead sponsor
Johnson & Johnson Surgical Vision, Inc.
Responsible party
Sponsor
First posted
Aug 15, 2023
Start date
Sep 11, 2023
Primary completion
Dec 4, 2023
Completion
Dec 4, 2023
Last update
Feb 2, 2024

Study contacts

Johnson & Johnson Surgical Vision, Inc. Clinical Trial
study director · Johnson & Johnson Surgical Vision, Inc.

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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