Clinical trial NCT07006428: Visual Performance of Clareon PanOptix vs. a Comparable Multifocal Intraocular Lens
Official title: Visual Performance Differences Between Clareon PanOptix and a Comparable Multifocal Intraocular Lens
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age Related Cataracts
Keywords: Clareon PanOptix
Multifocal IOL
Cataract Surgery
Visual Acuity
Intraocular Lens
Lead sponsor: Argus Research Center, Inc.
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 290
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Binocular photopic BCDVA (4m)
timeFrame: 2.5 to 5 months postoperatively
measure: Binocular BCDVA (4m)
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Cape Coral
country: United States
facility: Tyson Eye
state: Florida
city: Gainesville
country: United States
facility: North Georgia Eye Associates
state: Georgia
Study officials:
References: