Cataracts
Conditions
Brief summary
Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.
Interventions
DEVICEIntervention
No study treatments will be administered during this study. However, data will be collected from medical records of patients who have been treated with the subject device of this study.
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who are bilaterally implanted with TECNIS PC IOL and are at least 45 days postoperative from their second eye surgery * Clear intraocular media * Signed informed consent and data protection documentation * Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures * Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided
Exclusion criteria
* Subjects with ongoing adverse events that might impact outcomes during the study * Use of systemic or ocular medication that may affect vision * Acute or chronic disease or condition, ocular trauma or surgery that may confound results * Patients with amblyopia, strabismus, nystagmus * Concurrent participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Symptoms | 3month postoperative | Patient questionnaires |
| Surgeon Experience | 3month postoperative | Questionnaire |
| Visual Acuity | 3month postoperative | Visual Acuity will be collected with standard clinical charts. |
Countries
Australia, Austria, France, Germany, India, Netherlands, South Korea, Spain
Contacts
STUDY_DIRECTORJohnson & Johnson Surgical Vision, Inc. Clinical Trial
Johnson & Johnson Surgical Vision, Inc.
Outcome results
None listed