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OpenTrials
Completed

NCT Number: NCT05799950

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

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).

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Key information

Conditions

Aphakia Cataract Eye Diseases Lens Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Oftalmologico Metropolitano, San Juan, Puerto Rico

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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.

Other names: Models MN50BM, MA60AC, MA60MA

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 5, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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