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Completed

NCT Number: NCT05827133

Effect of Intraocular Lens (IOL) Centration and Tilt on Visual Performance With 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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Lenses, Intraocular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

East Coast Institute for Research

Jacksonville, Florida, 32216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. CDVA100

    Time frame: 1 Day

    The mean between Monocular best-corrected distance visual acuity (CDVA100) (logMAR) (High Contrast - 100%).

  2. IOL Decentration

    Time frame: 1 day

    The mean value and standard deviation of IOL decentration.

  3. IOL Tilt

    Time frame: 1 day

    The mean value and standard deviation of IOL tilt.

Secondary outcomes

  1. UCDVA100

    Time frame: 1 day

    The mean between Uncorrected Distance Visual Acuity (UCDVA100) (logMAR) (High Contrast - 100%)

  2. UCIVA100

    Time frame: 1 day

    The mean between Uncorrected Intermediate Visual Acuity (UCIVA100) (logMAR) (High Contrast - 100%).

  3. DCIVA100

    Time frame: 1 day

    The mean between Distance Corrected Intermediate Visual Acuity (100%) (DCIVA100) (logMAR) (High Contrast - 100%).

  4. MRSE

    Time frame: 1 day

    The mean between Manifest Refraction Spherical Equivalent (MRSE) (D).

Other outcomes

  1. CDVA25

    Time frame: 1 day

    The mean between Corrected Distant Visual Acuity (logMAR) (Low Contrast - 25%).

  2. Mesopic Pupil Size

    Time frame: 1 day

    The mean between Mesopic Pupil Size (mm).

  3. HOA S

    Time frame: 1 day

    The mean between Higher-Order Aberration, Spherical (HOA S) (µm)

  4. HOA CH

    Time frame: 1 day

    The mean between Higher-Order Aberration- Coma, Horizontal (HOA CH).

  5. HOA CV

    Time frame: 1 day

    The mean between Higher-Order Aberration- Coma, Vertical (HOA CV) (µm).

Sponsors and collaborators

Lead sponsor

East Coast Institute for Research

Network

Collaborators

  • Alcon Research
  • Florida Eye Specialists

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2023
Registry last updated
Jul 10, 2026

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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