Age Related Cataracts
Conditions
Keywords
Clareon PanOptix, Multifocal IOL, Cataract Surgery, Visual Acuity, Intraocular Lens
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.
Interventions
DEVICEClareon PanOptix or PanOptix Toric IOLs
Bilateral implantation of the Clareon PanOptix or PanOptix Toric IOLs.
DEVICEComparable multifocal IOL
Bilateral implantation of a comparable multifocal IOL
Sponsors
Argus Research Center, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular photopic BCDVA (4m) | 2.5 to 5 months postoperatively |
| Binocular BCDVA (4m) | Month 3 |
Countries
United States
Outcome results
None listed