Recruiting

Clareon PanOptix vs. Multifocal IOL

Sponsor:

Argus Research Center, Inc.

Code:

NCT07006428

Conditions

Age Related Cataracts

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Clareon PanOptix or PanOptix Toric IOLs

Comparable multifocal IOL

Study Details

Brief summary:

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.

Conditions

Age Related Cataracts

Study ID

NCT07006428

Start date

May 7, 2025

Status verified date

May, 2025

Completion date

Nov, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

290 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clareon PanOptix or PanOptix Toric IOLs

experimental: Comparable multifocal IOL

Interventions

Clareon PanOptix or PanOptix Toric IOLs

Bilateral implantation of the Clareon PanOptix or PanOptix Toric IOLs.

Comparable multifocal IOL

Bilateral implantation of a comparable multifocal IOL

Primary outcome measure

  • Binocular photopic BCDVA (4m) [ Time Frame: 2.5 to 5 months postoperatively ]
  • Binocular BCDVA (4m) [ Time Frame: Month 3 ]

Central Contacts and Locations

Locations

Wolstan & Goldberg Eye Associates

Recruiting

Torrance, California, United States, 90505

Contacts

Cynthia Montes

(310) 543-2611cynthia@wgeye.com

Tyson Eye

Recruiting

Cape Coral, Florida, United States, 33904

Contacts

Angela Hartline

(239) 542-2020angela.hartline@tysoneye.com

North Georgia Eye Associates

Recruiting

Gainesville, Georgia, United States, 30501

Contacts

MaryAnn Thomas

470-870-7311matyann.thomas@ngeye.com

More Information

Sponsor

Argus Research Center, Inc.

Last update posted

Jun 5, 2025

Last verified

May, 2025

Keywords

  • Clareon PanOptix
  • Multifocal IOL
  • Cataract Surgery
  • Visual Acuity
  • Intraocular Lens

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Argus Research Center, Inc. on 2025-06-05.