Completed
Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
What is being collected
Data Collection
Collected from past medical records and data - RetrospectiveWho is being recruted
Cataract
+ Eye Diseases
+ Lens Diseases
+10 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: September 2023
Summary
Principal SponsorJohnson & Johnson Surgical Vision, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 11, 2023
Actual date on which the first participant was enrolled.Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
Official TitleEvaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
Principal SponsorJohnson & Johnson Surgical Vision, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
96 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
CataractEye DiseasesLens Diseases
Criteria
4 inclusion criteria required to participate
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.
6 exclusion criteria prevent from participating
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;
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 12 locations
Suspended
Suspended
The Eye Institute of West Florida
Largo, United StatesSuspended
Center for Sight
Sarasota, United StatesSuspended
Aloha Vision Consultants
Honolulu, United StatesCompleted12 Study Centers