CataractsNCT05991960
Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
An observational study of Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 12 sites in United States.
Trial summary
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataracts
- What is being tested?
- Intervention
- Type of treatment
- Medical device
- How many people
- 96 participants
- Where
- 12 sitesUnited States
- Study dates
- 11 Sep 2023to 4 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pseudophakic patients previously bilaterally implanted with TECNIS Odyssey IOL.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Dell Laser Consultants
Austin, Texas, 78746
Assil Eye Institute
Beverly Hills, California, 90210
Cleveland Eye Clinic
Brecksville, Ohio, 44141
OCLI Vision
Garden City, New York, 11530
Loden Vision Centers
Goodlettsville, Tennessee, 37072
Aloha Vision Consultants
Honolulu, Hawaii, 96816
Whitsett Vision Group
Houston, Texas, 77055
The Eye Institute of West Florida
Largo, Florida, 33770
Carolina EyeCare Physicians
Mt. Pleasant, South Carolina, 29464
Virginia Eye Consultants
Norfolk, Virginia, 23502
Center for Sight
Sarasota, Florida, 34239
Vance Thompson Vision
West Fargo, North Dakota, 58078
About this study
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
- Conditions
- Cataracts
- Being tested
- Intervention
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual Acuity will be collected via observed case data in units of logMAR.
Measured: 1-month postoperative
Manifest Refraction
Manifest Refraction will be collected via observed case data in units of diopters.
Measured: 1-month postoperative
Visual Symptoms/Complaints
Visual Symptoms/Complaints will be measured using a questionnaire on a 5-point scale.
Measured: 1-month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start11 Sep 2023
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Surgical Vision, Inc. Clinical Trial, Study director, Johnson & Johnson Surgical Vision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991960
- Sponsor's protocol ID
- DIOL112MRWD
- Status last verified
- Feb 2024
- First submitted
- 7 Aug 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
- ClinicalTrials.gov ID
- NCT05991960
- Acronym / sponsor ID
- DIOL112MRWD
- Conditions
- Cataracts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pseudophakic patients previously bilaterally implanted with TECNIS Odyssey IOL.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionNo 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. | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Surgical Vision, Inc. Clinical Trial study director
Johnson & Johnson Surgical Vision, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataracts, run by Johnson & Johnson Surgical Vision, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: 1-month postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.