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

• Sponsor: Johnson & Johnson Surgical Vision, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06005675
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Anticipated Duration (Months): 2.3
• Patients Per Site: 16.7
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Device: Intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL
• Anticipated Study Start Date: Aug 21, 2023
• Anticipated Primary Completion Date: Oct 31, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Outcome Measures

Primary Outcome Measures

1. Visual Acuities [1-month postoperative]

   Visual Acuity will be collected via observed case data in units of logMAR.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Empire Eye and Laser Center	Bakersfield	California	United States	93309
2	Waring Vision Institute	Mount Pleasant	South Carolina	United States	29464
3	Vance Thompson Vision	Sioux Falls	South Dakota	United States	57108

Sponsors and Collaborators

• Johnson & Johnson Surgical Vision, Inc.

Investigators

• Study Director: Johnson & Johnson, Surgical Vision Inc. Clinical Trial, Johnson & Johnson Surgical Vision, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Surgical Vision, Inc.
• ClinicalTrials.gov Identifier: NCT06005675
• Other Study ID Numbers: DIOL111MOLS
• First Posted: Aug 22, 2023
• Last Update Posted: Aug 22, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Aug 22, 2023