Actively Recruiting
Visual Performance of Clareon PanOptix vs. a Comparable Multifocal Intraocular Lens
Led by Argus Research Center, Inc. · Updated on 2025-06-05
290
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Visual Performance of Clareon PanOptix vs. a Comparable Multifocal Intraocular Lens
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to understand and sign informed consent.
- Adult patients previously diagnosed with bilateral age-related cataracts.
- Previous bilateral age-related cataract removal with bilateral implantation of Clareon PanOptix/PanOptix Toric or comparable multifocal IOL, 2.5-5 months after implantation and more than 2 weeks post YAG (if done), targeted for emmetropia.
- Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes preoperatively or postoperatively as determined by surgeon.
- Normal ocular findings aside from cataract.
- Planned bilateral cataract removal by femtosecond laser-assisted phacoemulsification with bilateral implantation of Clareon PanOptix/PanOptix Toric or comparable multifocal IOL.
- Residual astigmatism expected to be 60.50 diopters in both eyes postoperatively as determined by surgeon (after toric IOL or arcuate incision).
You will not qualify if you...
- Corneal pathology, irregular astigmatism, preexisting macular or retinal degenerative diseases expected to cause vision loss.
- Diabetic retinopathy 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 results.
- Patients with monovision correction or desiring monovision.
- Any active ocular infection or inflammation.
- History of amblyopia or monofixation syndrome with poor stereoscopic vision.
- Total corneal higher-order aberrations greater than 0.6um or coma less than 0.3um at 4-5 mm scan.
- Planned simultaneous or combined procedures at time of cataract surgery (e.g., MIGs).
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Wolstan & Goldberg Eye Associates
Torrance, California, United States, 90505
Actively Recruiting
2
Tyson Eye
Cape Coral, Florida, United States, 33904
Actively Recruiting
3
North Georgia Eye Associates
Gainesville, Georgia, United States, 30501
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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