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Trial record 1 of 1 for:    NCT05991960
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Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL

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ClinicalTrials.gov Identifier: NCT05991960
Recruitment Status : Completed
First Posted : August 15, 2023
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Surgical Vision, Inc.

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

Condition or disease Intervention/treatment
Cataracts Device: Intervention

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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
Actual Study Start Date : September 11, 2023
Actual Primary Completion Date : December 4, 2023
Actual Study Completion Date : December 4, 2023

Intervention Details:
  • Device: Intervention
    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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pseudophakic patients previously bilaterally implanted with TECNIS Odyssey IOL.
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05991960


Locations
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United States, California
Assil Eye Institute
Beverly Hills, California, United States, 90210
United States, Florida
The Eye Institute of West Florida
Largo, Florida, United States, 33770
Center for Sight
Sarasota, Florida, United States, 34239
United States, Hawaii
Aloha Vision Consultants
Honolulu, Hawaii, United States, 96816
United States, New York
OCLI Vision
Garden City, New York, United States, 11530
United States, North Dakota
Vance Thompson Vision
W. Fargo, North Dakota, United States, 58078
United States, Ohio
Cleveland Eye Clinic
Brecksville, Ohio, United States, 44141
United States, South Carolina
Carolina EyeCare Physicians
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Loden Vision Centers
Goodlettsville, Tennessee, United States, 37072
United States, Texas
Dell Laser Consultants
Austin, Texas, United States, 78746
Whitsett Vision Group
Houston, Texas, United States, 77055
United States, Virginia
Virginia Eye Consultants
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Johnson & Johnson Surgical Vision, Inc.
Investigators
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Study Director: Johnson & Johnson Surgical Vision, Inc. Clinical Trial Johnson & Johnson Surgical Vision, Inc.
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Responsible Party: Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier: NCT05991960    
Other Study ID Numbers: DIOL112MRWD
First Posted: August 15, 2023    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
URL: http://yoda.yale.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases