Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance With Clareon® Vivity® IOL Implantation

A Non-Interventional Study to Evaluate the Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance in Patients Who Have Undergone Clareon® Vivity® IOL Implantation

The goal of this observational study is to assess the effect of intraocular lens (IOL) movement in patients who have undergone Clareon® Vivity® IOL implantation.

The main question it aims to answer is: Does an association exist between IOL movement and patient quality of vision?

Participants implanted with Clareon® Vivity® and Vivity® Toric IOLs will be asked to do the following:

• consent to participate in the study
• allow researchers to access their personal medical records
• undergo a series of tests to assess the position of their IOLs and quality of vision

Researchers will assess participant examination results to determine whether an association exists between IOL movement and patient quality of vision.

Study Overview

• Status: Completed
• Conditions: Cataract; Lenses, Intraocular
• Intervention / Treatment: Other: No intervention

Detailed Description

This is a non-interventional, single-center, multi-surgeon, observational study to evaluate the effect of intraocular lens (IOL) centration and tilt on visual performance in patients who have undergone Clareon® Vivity® IOL implantation. The study population will include individuals implanted with Clareon® Vivity® and Vivity® Toric IOLs. IOL implantations reviewed will range from the earliest performed (May 2022) onward, until 100 implanted patients (200 eyes) are enrolled. Potential subjects will be consented, then retrospective chart review of pre-operative and operative implantation data will occur and postoperative data will be collected (1 or more months post-operation) via examination.

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include approximately 100 adult participants (200 eyes) who have previously been implanted with Clareon® Vivity® and Vivity® Toric intraocular lenses (IOLs).

Description

Inclusion Criteria:

• Age ≥ 18 years
• History of adult cataract and uneventful, refractive cataract surgery with Clareon® Vivity® or Vivity® Toric intraocular lens (IOL) implantation with manifest refraction spherical equivalent (MRSE) within ±1.00 D
• Willing to undergo an eye exam with pupil dilation

Exclusion Criteria:

• Moderate to severe posterior capsule opacification (2+ or more)
• Yttrium aluminum garnet (YAG) laser capsulotomy within 1 month prior to enrollment
• Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) within the one year prior to IOL implantation or any time after IOL implantation
• Any previous ocular surgery (excluding YAG, LASIK, PRK)
• Clinically significant ocular pathology; severe diabetic retinopathy, age-related macular degeneration (AMD), glaucoma, severe dry eye, irregular astigmatism, zonular weakness, pseudoexfoliation, ocular trauma
• Any additional procedure(s) at the same time as the Vivity implantation including but not limited to microinvasive glaucoma surgery (MIGS)
• Women who are pregnant at the time of screening (based on self-reported history)
• Medical or other problems which in the opinion of the investigator will render study participation unsafe

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Monocular best-corrected distance visual acuity (BCDVA) (4 m) (logMAR)	Visit 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Decentration of intraocular lens (IOL) (mm)	Visit 1
Tilt of intraocular lens (IOL) (°)	Visit 1
Monocular uncorrected distance visual acuity (UCDVA) (4 m) (logMAR)	Visit 1
Monocular distance-corrected intermediate visual acuity (DCIVA) (66 cm) (logMAR)	Visit 1
Monocular uncorrected intermediate visual acuity (UCIVA) (66 cm) (logMAR)	Visit 1
Manifest refraction/Manifest refraction spherical equivalent (MRSE) (D)	Visit 1

Other Outcome Measures

Outcome Measure	Time Frame
Mesopic pupil size (mm)	Visit 1
Mean photopic low contrast (25%) monocular best-corrected distance visual acuity (BDCVA) (4 m) (logMAR)	Visit 1
Coma higher-order aberration (HOA) (µm)	Visit 1
Spherical higher-order aberration (HOA) (µm)	Visit 1

Collaborators and Investigators

• Sponsor: East Coast Institute for Research
• Collaborators: Alcon Research; Florida Eye Specialists

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): July 23, 2024
• Study Completion (Actual): July 23, 2024

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Toric Lens; Tilt; Extended Depth of Focus Lens; Decentration; Clareon Vivity; Clareon Vivity Toric
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ECIR-Alcon-01

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