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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-28

Study Completion Date

2025-06-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Visual Performance of Bilateral AcrySof ReSTOR Aspheric +4

NCT01215045

Cataract

COMPLETED

Evaluation of Long-term Safety and Performance of PanOptix Intraocular Lens (IOLs)

NCT06166901

Aphakia Astigmatism Presbyopia

COMPLETED NA

Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

NCT02176343

Cataract Presbyopia Corneal Astigmatism

COMPLETED NA

Evaluation of AcrySof IQ Vivity Extended Vision Intraocular Lenses

NCT06541795

Aphakia Presbyopia Residual Refractive Cylinder

WITHDRAWN NA

Pilot Study of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

NCT01200511

Cataract

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aphakia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AcrySof single-piece IOL

Pseudophakic subjects previously implanted with an AcrySof single-piece IOL

AcrySof single-piece IOL

Intervention Type DEVICE

Acrylic single-piece intraocular lens placed in the capsular bag in the posterior chamber of the eye during cataract surgery as a replacement for the natural crystalline lens.

AcrySof multi-piece IOL

Pseudophakic subjects previously implanted with an AcrySof multi-piece IOL

AcrySof multi-piece IOL

Intervention Type DEVICE

Acrylic multi-piece intraocular lens placed in the capsular bag in the posterior chamber of the eye during cataract surgery as a replacement for the natural crystalline lens.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AcrySof single-piece IOL

Acrylic single-piece intraocular lens placed in the capsular bag in the posterior chamber of the eye during cataract surgery as a replacement for the natural crystalline lens.

Intervention Type DEVICE

AcrySof multi-piece IOL

Acrylic multi-piece intraocular lens placed in the capsular bag in the posterior chamber of the eye during cataract surgery as a replacement for the natural crystalline lens.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Models SN60WF, ACU0T0, SN6AT2, SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, SN6AT9, SA6AT2, SA6AT3, SA6AT4, SA6AT5, SA6AT6, SA6AT7, SA6AT8, SA6AT9 Models MN50BM, MA60AC, MA60MA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.