A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses

Alcon

Status: Invitation-only

Conditions: Aphakia

Treatments: Device: AcrySof multi-piece IOL; Device: AcrySof single-piece IOL

Study type: Observational

Funder types: Industry

Identifiers

NCT05799950

ILB609-N001

Details and patient eligibility

About

The purpose of this post-market clinical follow-up (PMCF) study is to describe the long-term safety and performance of AcrySof Single-Piece and AcrySof Multi-Piece monofocal intraocular lenses (IOLs).

Full description

The study includes a retrospective chart review for pre-operative, operative, and post-operative data collection, and a prospective, standard-of-care visit to collect study endpoints.

Enrollment: 230 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subject is implanted with one of the study IOL models between 3 and 5 years previously.
• Subject follow-up is expected to be possible during the duration of the study.
• Subject or legally authorized representative must be able to understand and sign the IRB/EC approved Informed Consent form. Minor subjects will complete an Assent Form.
• Documented medical history and required pre-operative baseline information is available for retrospective data collection.

Key Exclusion Criteria:

• Subject is participating in a separate investigational drug or device study.
• Pregnancy at the time of enrollment.

Trial design

230 participants in 2 patient groups

AcrySof single-piece IOL

Description:

Pseudophakic subjects previously implanted with an AcrySof single-piece IOL

Treatment:

Device: AcrySof single-piece IOL

AcrySof multi-piece IOL

Description:

Pseudophakic subjects previously implanted with an AcrySof multi-piece IOL

Treatment:

Device: AcrySof multi-piece IOL