NCT05827133

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: East Coast Institute for Research · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cataract
• Lenses, Intraocular

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

• Start date: 2023-07-10
• Primary completion: 2024-07-23
• Completion: 2024-07-23
• First posted: 2023-04-24
• Last updated: 2024-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study