About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Clareon PanOptix or PanOptix Toric IOLs
- Comparable multifocal IOL