Visual Performance of Clareon PanOptix vs. a Comparable Multifocal Intraocular Lens

May 28, 2025 updated by: Argus Research Center, Inc.

Visual Performance Differences Between Clareon PanOptix and a Comparable Multifocal Intraocular Lens

This is a two-part, multi-center, investigator-initiated clinical study comparing visual outcomes and patient satisfaction in subjects receiving bilateral implantation of either the Clareon PanOptix intraocular lens (IOL) or a comparable multifocal IOL. The study includes a retrospective/prospective pilot phase and a prospective, randomized comparison phase.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90505
        • Recruiting
        • Wolstan & Goldberg Eye Associates
        • Contact:
    • Florida
      • Cape Coral, Florida, United States, 33904
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • North Georgia Eye Associates
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Stage 1: IIT Pilot

  • Willing and able to understand and sign informed consent.
  • Adult patients previously diagnosed with age-related cataracts bilaterally.
  • Previous bilateral age-related cataract removal and with bilateral implantation of the Clareon PanOptix/ Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4) closest to 2.5-5-months after implantation and >2 weeks post YAG (if done) that were targeted for emmetropia.
  • Best monocular corrected distance visual acuity was expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon.
  • Normal ocular findings aside from cataract.

Stage 2: Comparison

  • Willing and able to understand and sign informed consent.
  • Adult patient diagnosed with age-related cataracts bilaterally.
  • Planned bilateral cataract removal by femtosecond laser-assisted phacoemulsification with bilateral implantation of the Clareon PanOptix/Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4).
  • Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon.
  • Residual astigmatism expected to be ≤ 0.50 diopters in both eyes postoperatively as determined by surgeon (after using either toric IOL or arcuate incision with laser).
  • Normal ocular findings aside from cataract.

Exclusion Criteria:

Stage 1: IIT Pilot

  • Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
  • Previous history of any ocular surgery including corneal refractive surgery.
  • Participation in another clinical study that could interfere with the results.
  • Patients with monovision correction.
  • Any active ocular infection or inflammation.

Stage 2: Comparison

  • Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative
  • diseases that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
  • Previous history of any ocular surgery including corneal refractive surgery.
  • Participants desiring monovision.
  • History of amblyopia or monofixation syndrome with poor stereoscopic vision.
  • Total corneal HOA greater than 0.6um, coma less than 0.3um at 4mm-5mm scan depending on pre- op photopic topography.
  • Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs).
  • Participation in another clinical study that could interfere with the results.
  • Any active ocular infection or inflammation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clareon PanOptix or PanOptix Toric IOLs
Device: Clareon PanOptix or PanOptix Toric IOLs
Bilateral implantation of the Clareon PanOptix or PanOptix Toric IOLs.
Experimental: Comparable multifocal IOL
Device: Comparable multifocal IOL
Bilateral implantation of a comparable multifocal IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Binocular photopic BCDVA (4m)
Time Frame: 2.5 to 5 months postoperatively
2.5 to 5 months postoperatively
Binocular BCDVA (4m)
Time Frame: Month 3
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Argus Research Center, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

May 28, 2025

First Submitted That Met QC Criteria

May 28, 2025

First Posted (Estimated)

June 5, 2025

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUPER-IIT-96028407

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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