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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
California
Wolstan & Goldberg Eye Associates
RECRUITING
Torrance
Florida
Tyson Eye
RECRUITING
Cape Coral
Georgia
North Georgia Eye Associates
RECRUITING
Gainesville
Time Frame
Start Date: 2025-05-07
Estimated Completion Date: 2025-11
Participants
Target number of participants: 290
Treatments
Experimental: Clareon PanOptix or PanOptix Toric IOLs
Experimental: Comparable multifocal IOL
Related Therapeutic Areas
Sponsors
Leads: Argus Research Center, Inc.

This content was sourced from clinicaltrials.gov