Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05991960 |
Recruitment Status :
Completed
First Posted : August 15, 2023
Last Update Posted : February 2, 2024
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Condition or disease | Intervention/treatment |
---|---|
Cataracts | Device: Intervention |
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 |
- 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.
- Visual Acuity [ Time Frame: 1-month postoperative ]Visual Acuity will be collected via observed case data in units of logMAR.
- Manifest Refraction [ Time Frame: 1-month postoperative ]Manifest Refraction will be collected via observed case data in units of diopters.
- Visual Symptoms/Complaints [ Time Frame: 1-month postoperative ]Visual Symptoms/Complaints will be measured using a questionnaire on a 5-point scale.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
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
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 |
Study Director: | Johnson & Johnson Surgical Vision, Inc. Clinical Trial | Johnson & Johnson Surgical Vision, Inc. |
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 |
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 |
Cataract Lens Diseases Eye Diseases |