Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens

To evaluate visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix intraocular lens (IOL) targeted for emmetropia.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: The Clareon™ PanOptix™ Trifocal (toric and non-toric models)

Detailed Description

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Florida
    • Sebring, Florida, United States, 33870
      • Newsom Eye & Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for near, intermediate and distance vision, and who are considered appropriate candidates for trifocal lens implantation.

Description

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 spectacle independence using a trifocal IOL
• Meet the requirements for on-label implantation of the trifocal IOL
• Gender: Males and Females.
• Age: 40 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).
• Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.
• All eyes will be in the range of availability for Clareon PanOptix IOL and Clareon PanOptix Toric IOL. For cylinder below the Toric IOL indication (T3), an LRI will be used during surgery.

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.

• Patients with any corneal pathology (including corneal dystrophies, scaring, severe dry eye syndrome, irregular astigmatism, HOA) limiting or affecting visual potential.
• Patients with previous corneal refractive surgery.
• Patients with pre-existing ocular pathology, including maculopathy, ARMD, ERM, prior RD, and glaucoma limiting or affecting visual potential.
• Subjects who have an unstable 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The Clareon™ PanOptix™ Trifocal (toric and non-toric models); Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)	Device: The Clareon™ PanOptix™ Trifocal (toric and non-toric models); Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular Distance-corrected Near (40 cm) Visual Acuity	1 month postoperatively
Binocular Distance-corrected Near (40 cm) Visual Acuity	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Uncorrected Distance (6 m) Visual Acuity		1 and 3 months postoperative
Binocular Uncorrected Intermediate (60 cm) Visual Acuity		1 and 3 months postoperative
Binocular Uncorrected Near (40 cm) Visual Acuity		1 and 3 months postoperative
Binocular Corrected Corrected Distance (6 m) Visual Acuity		1 and 3 months postoperative
Binocular Distance-corrected Intermediate (60 cm) Visual Acuity		1 and 3 months postoperative
Manifest Refraction	spherical equivalent refraction and astigmatism less than or equal to 0.5 D.	3 months postoperative
Satisfaction Questionnaire	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Subjects were asked how often they needed to wear eyeglasses to see at distance, intermediate, and near. The percentage was calculated as (# of subjects responding "Never" or "Rarely") divided by (# of subjects) times 100. A higher percentage is a better outcome.	3 months postoperative
Visual Disturbances Questionnaire	Questionnaire for Visual Disturbances (QUVID).	3 months postoperative

Other Outcome Measures

Outcome Measure	Time Frame
Binocular distance-corrected near (40 cm) visual acuity	1 and 3 months postoperative

Collaborators and Investigators

• Sponsor: Newsom Eye & Laser Center
• Collaborators: Sengi
• Investigators: Principal Investigator: Thomas H Newsom, MD, Newsom Eye & Laser Center

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Actual): June 14, 2024
• Study Completion (Actual): June 14, 2024

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: THN-22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes