Clareon TruPlus vs Tecnis Eyhance IOLs for cataract surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, two-arm, single-center, single-surgeon study that doubles-masks both participants and assessors. Participants will undergo bilateral cataract removal with implantation of either Clareon TruPlus IOL or Tecnis Eyhance IOL, followed by a 3-month postoperative assessment. The study collects pre-operative and postoperative data to compare outcomes related to vision and refractive results. It will be conducted at one site with a single surgeon to minimize variability. Key eligibility requires bilateral cataracts, acceptable expected postoperative visual acuity, and residual astigmatism within target ranges.

Why it matters

Who can join: the full rules

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.

Where it's running

• North Georgia Eye Associates
  Gainesville, Georgia, United States Recruiting

Study contacts

• Principal investigator: Clayton Blehm, MD — North Georgia Eye Associates
• Study coordinator: Maryann Thomas
• Email: maryann.thomas@ngeye.com
• Phone: 770-532-4444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.