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

Study Overview
=================
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 compare the patients' preoperative and postoperative test 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 reached. 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.

Official 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

Conditions
-----------------
Lenses, Intraocular, Cataract

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals implanted with Clareon® Vivity® or Vivity® Toric Intraocular Lenses (IOLs)<br> | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extended Depth of Focus Lens, Toric Lens, Decentration, Tilt, Clareon Vivity, Clareon Vivity Toric