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

Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05991960
Collaborator
(none)
100
Enrollment
12
Locations
2.6
Anticipated Duration (Months)
8.3
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Intervention

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of Real-World Data on the Performance of the TECNIS Odyssey™ IOL
Anticipated Study Start Date :
Aug 14, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity [1-month postoperative]

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

  2. Manifest Refraction [1-month postoperative]

    Manifest Refraction will be collected via observed case data in units of diopters.

  3. Visual Symptoms/Complaints [1-month postoperative]

    Visual Symptoms/Complaints will be measured using a questionnaire on a 5-point scale.

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 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assil Eye Institute Beverly Hills California United States 90210
2 The Eye Institute of West Florida Largo Florida United States 33770
3 Center for Sight Sarasota Florida United States 34239
4 Aloha Vision Consultants Honolulu Hawaii United States 96816
5 OCLI Vision Garden City New York United States 11530
6 Vance Thompson Vision W. Fargo North Dakota United States 58078
7 Cleveland Eye Clinic Brecksville Ohio United States 44141
8 Carolina EyeCare Physicians Mount Pleasant South Carolina United States 29464
9 Loden Vision Centers Goodlettsville Tennessee United States 37072
10 Dell Laser Consultants Austin Texas United States 78746
11 Whitsett Vision Group Houston Texas United States 77055
12 Virginia Eye Consultants Norfolk Virginia United States 23502

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:
NCT05991960
Other Study ID Numbers:
  • DIOL112MRWD
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 16, 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 16, 2023