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

NCT05518539 | Completed Results FDA Device

• 1 other identifier: THN-22-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• Binocular Distance-corrected Near (40 cm) Visual Acuity

  1 month postoperatively

• Binocular Distance-corrected Near (40 cm) Visual Acuity

  3 months postoperatively

Secondary Outcomes (8)

• 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

Study Arms (1)

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)

Interventions

The Clareon™ PanOptix™ Trifocal (toric and non-toric models) DEVICE

Bilateral implantation with the Clareon PanOptix Trifocal (toric and non-toric models)

The Clareon™ PanOptix™ Trifocal (toric and non-toric models)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newsom Eye & Laser Center: lead
• Sengi: collaborator

Study Sites (1)

Newsom Eye & Laser Center

Sebring, Florida, 33870, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: T Hunter Newsom
• Organization: Newsom Eye

hunter@newsomeye.net

813-908-2020

Study Officials

• Thomas H Newsom, MD

  Newsom Eye & Laser Center

  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: August 24, 2022
• First Posted: August 26, 2022
• Study Start: September 8, 2022
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: July 18, 2025
• Results First Posted: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)