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

NCT ID: NCT04936256

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-02
• Study Completion Date: 2022-07-28

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.

Conditions

Cataract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Bilateral implantation of the Clareon monofocal IOL

Clareon monofocal intraocular lens (IOL)

Clareon

Intervention Type: DEVICE

Clareon monofocal intraocular lens (IOL)

Interventions

Clareon

Clareon monofocal intraocular lens (IOL)

Intervention Type: DEVICE

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

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sengi

INDUSTRY

Sponsor Role: collaborator

Gainesville Eye Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clayton Blehm, MD

Role: PRINCIPAL_INVESTIGATOR

Gainesville Eye Associates

Locations

Gainesville Eye Associates

Gainesville, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CB-20-001

Identifier Type: -

Identifier Source: org_study_id