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

Completed

Conditions: Cataract

Interventions: Device: Clareon

Registration Number: NCT04936256

Lead Sponsor: Gainesville Eye Associates

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bilateral implantation of the Clareon monofocal IOL	Clareon	Clareon monofocal intraocular lens (IOL)

Primary Outcome Measures

Name	Time	Method
Refractive Stability	3 months	Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months)

Secondary Outcome Measures

Name	Time	Method
Binocular Corrected Distance Visual Acuity	3 months	Binocular corrected distance visual acuity in logMAR
Binocular Distance-corrected Intermediate Visual Acuity	3 months	Binocular distance-corrected intermediate visual acuity in logMAR
Binocular Defocus Curve	3 months	A binocular defocus curve is obtained by measuring visual acuity (logMAR) at different spherical powers (D).
Binocular Uncorrected Intermediate Visual Acuity	3 months	Binocular uncorrected intermediate visual acuity in logMAR
Binocular Uncorrected Distance Visual Acuity	3 months	Binocular uncorrected distance visual acuity in logMAR