Clinical trial NCT05991960: Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
Official title: Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataracts
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-15
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pseudophakic patients previously bilaterally implanted with TECNIS Odyssey IOL.

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


Eligibility 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.

Primary outcomes:
measure: Visual Acuity
timeFrame: 1-month postoperative
measure: Manifest Refraction
timeFrame: 1-month postoperative
measure: Visual Symptoms/Complaints
timeFrame: 1-month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Assil Eye Institute
state: California
city: Largo
country: United States
facility: The Eye Institute of West Florida
state: Florida
city: Sarasota
country: United States
facility: Center for Sight
state: Florida
city: Honolulu
country: United States
facility: Aloha Vision Consultants
state: Hawaii
city: Garden City
country: United States
facility: OCLI Vision
state: New York
city: W. Fargo
country: United States
facility: Vance Thompson Vision
state: North Dakota
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Mount Pleasant
country: United States
facility: Carolina EyeCare Physicians
state: South Carolina
city: Goodlettsville
country: United States
facility: Loden Vision Centers
state: Tennessee
city: Austin
country: United States
facility: Dell Laser Consultants
state: Texas
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Johnson & Johnson Surgical Vision, Inc.
name: Johnson & Johnson Surgical Vision, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: