A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens

Johnson & Johnson (J&J)

Status: Completed

Conditions: Cataracts

Treatments: Device: Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06250322

PCOL204APME

Details and patient eligibility

About

Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.

Enrollment: 307 patients

Sex: All

Volunteers: No Healthy Volunteers

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