Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months).

Detailed Description
-----------------
This study is a single-arm, evaluator masked clinical evaluation study of refractive stability, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and defocus curve.

Official Title
-----------------
Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Clareon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes. Presenting for uncomplicated bilateral cataract surgery and have an interest in an IOL option Gender: Males and Females. Age: 50 or older Willing and able to provide written informed consent for participation in the study Willing and able to comply with scheduled visits and other study procedures. Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract) Potential postoperative visual acuity of (20/25 Snellen) or better in both eyes Exclusion Criteria: If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. Irregular astigmatism (e.g. keratoconus) Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye) Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty) Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy) Diabetic retinopathy Macular pathology (e.g. ARMD, ERM) History of retinal detachment Any patient based on Barrett toric calculator that will have ≥ 0.75D residual astigmatism if Clareon® non-toric IOL is implanted Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating) The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bilateral implantation of the Clareon monofocal IOL<br>Clareon monofocal intraocular lens (IOL) | Device: Clareon<br>* Clareon monofocal intraocular lens (IOL)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive stability | Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular uncorrected distance visual acuity | Binocular uncorrected distance visual acuity | 3 months | 
| Binocular uncorrected intermediate visual acuity | Binocular uncorrected intermediate visual acuity | 3 months | 
| Binocular best-corrected distance visual acuity | Binocular best-corrected distance visual acuity | 3 months | 
| Binocular best-corrected intermediate visual acuity | Binocular best-corrected intermediate visual acuity | 3 months | 
| Binocular defocus curve | Binocular defocus curve | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Monofocal IOL, Clareon