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

NCT04936256 | Completed Results FDA Device

• 1 other identifier: CB-20-001
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Keywords

Monofocal IOL; Clareon

Outcome Measures

Primary Outcomes (1)

• Refractive Stability

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

  3 months

Secondary Outcomes (5)

• Binocular Uncorrected Distance Visual Acuity

  3 months

• Binocular Uncorrected Intermediate Visual Acuity

  3 months

• Binocular Corrected Distance Visual Acuity

  3 months

• Binocular Distance-corrected Intermediate Visual Acuity

  3 months

• Binocular Defocus Curve

  3 months

Study Arms (1)

Bilateral implantation of the Clareon monofocal IOL

Clareon monofocal intraocular lens (IOL)

Device: Clareon

Interventions

Clareon DEVICE

Clareon monofocal intraocular lens (IOL)

Bilateral implantation of the Clareon monofocal IOL

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects ≥50 years of age presenting for cataract surgery who are appropriate candidates for intraocular lens implantation.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gainesville Eye Associates: lead
• Sengi: collaborator

Study Sites (1)

Gainesville Eye Associates

Gainesville, Georgia, 30501, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Clayton Blehm, MD
• Organization: Gainesville Eye Associates

claytonblehm@gmail.com

7705324444

Study Officials

• Clayton Blehm, MD

  Gainesville Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 23, 2021
• Study Start: July 2, 2021
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)