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

NCT07006428 | Recruiting FDA Device

• 1 other identifier: SUPER-IIT-96028407
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Binocular photopic BCDVA (4m)

  2.5 to 5 months postoperatively

• Binocular BCDVA (4m)

  Month 3

Study Arms (2)

Clareon PanOptix or PanOptix Toric IOLs

EXPERIMENTAL

Device: Clareon PanOptix or PanOptix Toric IOLs

Comparable multifocal IOL

EXPERIMENTAL

Device: Comparable multifocal IOL

Interventions

Clareon PanOptix or PanOptix Toric IOLs DEVICE

Bilateral implantation of the Clareon PanOptix or PanOptix Toric IOLs.

Clareon PanOptix or PanOptix Toric IOLs

Comparable multifocal IOL DEVICE

Bilateral implantation of a comparable multifocal IOL

Comparable multifocal IOL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Argus Research Center, Inc.: lead

Study Sites (3)

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

RECRUITING

Tyson Eye

Cape Coral, Florida, 33904, United States

RECRUITING

North Georgia Eye Associates

Gainesville, Georgia, 30501, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: May 7, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)