Clareon TruPlus vs Tecnis Eyhance IOLs in Cataract Patients

Visual and Patient Reported Outcomes Comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in Normal Cataract Patients: Stage 1

This study is a prospective, randomized, two-arm, single-center, single-surgeon, double-masked (subject and assessor) comparative study. It involves bilateral implantation of intraocular lenses (IOLs), comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in normal cataract patients. The study will be conducted at one site and will include a pre-operative visit and a 3-month post-operative assessment.

Inclusion Criteria:

• Willing and able to understand and sign informed consent.
• Adult patient diagnosed with age-related cataracts bilaterally.
• Planned bilateral cataract removal and with bilateral implantation of the Clareon TruPlus IOL/Toric BLF (T3-T5) or Tecnis Eyhance IOL/Eyhance Toric (equivalent to T3-T5).
• 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 or manual LRI).
• Normal ocular findings aside from cataract.

Exclusion Criteria:

• Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases 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.
• History of amblyopia or monofixation syndrome with poor stereoscopic vision.
• Participants desiring monovision.
• 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.