Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL

Cataracts Clinical Trial

Official title:

Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05991960
• Other study ID #: DIOL112MRWD
• Status: Completed
• Start date: September 11, 2023
• Est. completion date: December 4, 2023

Study information

• Verified date: February 2024
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 4, 2023
• Est. primary completion date: December 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

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.

Locations

Country	Name	City	State
United States	Dell Laser Consultants	Austin	Texas
United States	Assil Eye Institute	Beverly Hills	California
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	OCLI Vision	Garden City	New York
United States	Loden Vision Centers	Goodlettsville	Tennessee
United States	Aloha Vision Consultants	Honolulu	Hawaii
United States	Whitsett Vision Group	Houston	Texas
United States	The Eye Institute of West Florida	Largo	Florida
United States	Carolina EyeCare Physicians	Mount Pleasant	South Carolina
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Center for Sight	Sarasota	Florida
United States	Vance Thompson Vision	W. Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Visual Acuity will be collected via observed case data in units of logMAR.	1-month postoperative
Primary	Manifest Refraction	Manifest Refraction will be collected via observed case data in units of diopters.	1-month postoperative
Primary	Visual Symptoms/Complaints	Visual Symptoms/Complaints will be measured using a questionnaire on a 5-point scale.	1-month postoperative