Cataracts Clinical Trial
Official title:
User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL
Verified date | May 2024 |
Source | Johnson & Johnson Surgical Vision, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective collection of data from medical records, multicenter, post-market clinical follow-up study.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Surgical Vision, Inc. |
United States,
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 |
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