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

August 13, 2025 updated by: Alcon Research
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00921
        • Centro Oftalmologico Metropolitano
  • United States
    • California
      • Burbank, California, United States, 91506
        • Velvet Clinical Research
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Levenson Eye Associates
    • Illinois
      • Rock Island, Illinois, United States, 61201
        • Virdi Eye Clinic
    • New York
      • Babylon, New York, United States, 11702
        • SightMD
    • Texas
      • Austin, Texas, United States, 78731
        • Texan Eye
      • Fort Worth, Texas, United States, 76107
        • Chu Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AcrySof single-piece IOL
Pseudophakic subjects previously implanted with an AcrySof single-piece IOL
Device: 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.
Other Names:
  • Models SN60WF, ACU0T0, SN6AT2, SN6AT3, SN6AT4, SN6AT5, SN6AT6, SN6AT7, SN6AT8, SN6AT9, SA6AT2, SA6AT3, SA6AT4, SA6AT5, SA6AT6, SA6AT7, SA6AT8, SA6AT9
AcrySof multi-piece IOL
Pseudophakic subjects previously implanted with an AcrySof multi-piece IOL
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.
Other Names:
  • Models MN50BM, MA60AC, MA60MA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean monocular best corrected distance visual acuity (BCDVA)
Time Frame: Up to 3 to 5 years post operative
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
Time Frame: Up to 3 to 5 years post operative

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean manifest refraction - Sphere
Time Frame: Up to 3-5 years postoperative
Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. The spherical component will be measured in diopters.
Up to 3-5 years postoperative
Mean manifest refraction - Cylinder
Time Frame: Up to 3-5 years postoperative
Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. The cylindrical component will be measured in diopters.
Up to 3-5 years postoperative
Mean manifest refraction - Axis
Time Frame: Up to 3-5 years postoperative
Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. The axial component will be measured in degrees.
Up to 3-5 years postoperative
Manifest refraction spherical equivalent (MRSE)
Time Frame: Up to 3-5 years postoperative
Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. MRSE will be calculated as [Sphere minus (cylinder divided by 2)] and reported in diopters.
Up to 3-5 years postoperative
Mean monocular uncorrected distance visual acuity (UCDVA)
Time Frame: Up to 3-5 years postoperative
Visual acuity will be assessed for each eye individually with no correction in place using letter charts placed at a distance of 6 meters (or 4 meters adjusted for infinity) from the subject. UCDVA will be measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.
Up to 3-5 years postoperative
Rate of additional adverse events - Ocular
Time Frame: Up to 3-5 years postoperative
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. This outcome measure will include all ocular adverse events other than the protocol-specified adverse events.
Up to 3-5 years postoperative
Rate of device deficiencies
Time Frame: Up to 3-5 years postoperative

The subject's medical records will be reviewed for device deficiencies. Examples of device deficiencies include the following:

  • Failure to meet product specifications (e.g., incorrect IOL power);
  • IOL defect;
  • Broken IOL optic;
  • Broken IOL haptic; Scratched IOL optic;
  • Unsealed device packaging;
  • Suspected product contamination;
  • Lack of performance. A device deficiency may or may not be associated with subject harm.
Up to 3-5 years postoperative
Rate of posterior capsulotomies
Time Frame: Up to 3-5 years postoperative
Posterior capsulotomy is surgery performed on the back side of the capsular bag in the eye. A laser is used to make an opening in the cloudy capsule to allow light to pass through again for clear vision. The subject's medical records will be reviewed for the occurrence of posterior capsulotomy.
Up to 3-5 years postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Lead, Surgical, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2023

Primary Completion (Actual)

June 2, 2025

Study Completion (Actual)

June 2, 2025

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILB609-N001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe