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

NCT05827133 | Completed FDA Device

• 1 other identifier: ECIR-Alcon-01
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract; Lenses, Intraocular

Keywords

Extended Depth of Focus Lens; Toric Lens; Decentration; Tilt; Clareon Vivity; Clareon Vivity Toric

Outcome Measures

Primary Outcomes (1)

• Monocular best-corrected distance visual acuity (BCDVA) (4 m) (logMAR)

  Visit 1

Secondary Outcomes (6)

• 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

Other Outcomes (4)

• Mean photopic low contrast (25%) monocular best-corrected distance visual acuity (BDCVA) (4 m) (logMAR)

  Visit 1

• Mesopic pupil size (mm)

  Visit 1

• Coma higher-order aberration (HOA) (µm)

  Visit 1

Study Arms (1)

Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)

Other: No intervention

Interventions

No intervention OTHER

No intervention

Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• East Coast Institute for Research: lead
• Alcon Research: collaborator
• Florida Eye Specialists: collaborator

Study Sites (1)

East Coast Institute for Research

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: July 10, 2023
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)