User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL

Cataracts Clinical Trial

Official title:

User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06005675
• Other study ID #: DIOL111MOLS
• Status: Active, not recruiting
• Start date: September 6, 2023
• Est. completion date: May 31, 2024

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• 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 informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;

5. Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures;

6. Ability to understand, read, and write in English

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 until after completion of the study visits;

4. Ongoing adverse events that might impact study measurements, as determined by the investigator;

5. Acute or chronic disease or condition, ocular trauma, or surgery that may confound study measurements (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 study.

Locations

Country	Name	City	State
United States	Empire Eye and Laser Center	Bakersfield	California
United States	Waring Vision Institute	Mount Pleasant	South Carolina
United States	Vance Thompson Vision	Sioux Falls	South Dakota
United States	Center For Sight	Venice	Florida

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 Acuities	Visual Acuity will be collected via observed case data in units of logMAR.	1-month postoperative