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

NCT05799950 | Completed FDA Device

• 1 other identifier: ILB609-N001
• Study Type: observational
• Target: 138
• Locations: 2 countries
• Sites: 7

Brief Summary

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).

Conditions

Aphakia

Keywords

Intraocular lens; Cataract

Outcome Measures

Primary Outcomes (2)

• Mean monocular best corrected distance visual acuity (BCDVA)

  Retrospectively, the subject's medical records will be reviewed for assessments of BCDVA. Prospectively, visual acuity will be assessed for each eye individually with correction in place using letter charts placed at a distance of 6 meters (or 4 meters adjusted for infinity) from the subject. BCDVA will be reported in logarithm minimum angle of resolution (logMAR), where a logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight) and lower logMAR values indicate better visual acuity.

  Up to 3 to 5 years post operative

• Rate of protocol-specified ocular adverse events

  The subject's medical records will be reviewed for medical conditions. Medical conditions that started after initial exposure to the study model IOLs will be captured as adverse events. The following adverse events are pre-specified for this outcome measure: * Cystoid macular edema (CME) * Hypopyon * Endophthalmitis * Lens dislocation * Pupillary block * Retinal detachment * Secondary surgical interventions

  Up to 3 to 5 years post operative

Secondary Outcomes (8)

• Mean manifest refraction - Sphere

  Up to 3-5 years postoperative

• Mean manifest refraction - Cylinder

  Up to 3-5 years postoperative

• Mean manifest refraction - Axis

  Up to 3-5 years postoperative

• Manifest refraction spherical equivalent (MRSE)

  Up to 3-5 years postoperative

• Mean monocular uncorrected distance visual acuity (UCDVA)

  Up to 3-5 years postoperative

Study Arms (2)

AcrySof single-piece IOL

Pseudophakic subjects previously implanted with an AcrySof single-piece IOL

Device: AcrySof single-piece IOL

AcrySof multi-piece IOL

Pseudophakic subjects previously implanted with an AcrySof multi-piece IOL

Device: AcrySof multi-piece IOL

Interventions

AcrySof single-piece IOL 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.

Also known as: Models SN60WF, ACU0T0, SN6AT2, SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, SN6AT9, SA6AT2, SA6AT3, SA6AT4, SA6AT5, SA6AT6, SA6AT7, SA6AT8, SA6AT9

AcrySof single-piece IOL

AcrySof multi-piece IOL 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.

Also known as: Models MN50BM, MA60AC, MA60MA

AcrySof multi-piece IOL

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from clinical sites in the United States and Canada.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (7)

Velvet Clinical Research

Burbank, California, 91506, United States

Location

Levenson Eye Associates

Jacksonville, Florida, 32204, United States

Location

Virdi Eye Clinic

Rock Island, Illinois, 61201, United States

Location

SightMD

Babylon, New York, 11702, United States

Location

Texan Eye

Austin, Texas, 78731, United States

Location

Chu Eye Institute

Fort Worth, Texas, 76107, United States

Location

Centro Oftalmologico Metropolitano

San Juan, 00921, Puerto Rico

Location

MeSH Terms

Conditions

Aphakia; Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Clinical Lead, Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: August 28, 2023
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (6)