Bilateral Clareon IOLs in Cataract Patients: TruPlus vs Monofocal

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, bilateral implantation study in adults with visually significant cataracts. Participants receive either Clareon TruPlus or Clareon monofocal IOLs in both eyes, with spherical and toric models allowed based on preoperative planning. Subjects and postoperative examiners are masked to which IOL was implanted, while surgeons know the assignment. The primary endpoint is assessed at 3 months after surgery, and the study follows a parallel-group design at multiple centers. Outcomes focus on vision-related measures and safety of the two IOL options.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult cataract patients aged ≥22 years scheduled for cataract surgery in both eyes due to visually significant cataracts.
2. Ability to understand and sign an IRB/ethics committee-approved informed consent form.
3. Willingness and ability to attend all scheduled study visits as required by the protocol and complete all study testing procedures.
4. Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
5. Preoperative corneal astigmatism that can be corrected with a T3-T5 toric IOL, or with a spherical IOL plus LRIs/Aks, with either resulting in a predicted postoperative astigmatism \<0.50 D.
6. IOL power and, if toric, cylinder availability within labeled ranges for the assigned IOL family.
7. Ability to understand and complete study questionnaires.

Exclusion Criteria:

1. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding (by verbal confirmation).
2. Ocular conditions that could confound study results, including moderate-to-severe corneal pathology, irregular astigmatism, moderate-to-severe dry eye/ocular surface disease not optimized, preexisting retinal degenerative disease (e.g., age-related macular degeneration), diabetic retinopathy, or other clinically significant retinal pathology.
3. Any form of confirmed glaucomatous optic neuropathy or other optic nerve disease expected to affect visual function outcomes.
4. History of amblyopia, monofixation syndrome, or other binocular vision disorder with poor stereopsis that could confound binocular testing.
5. Prior ocular surgery (including corneal refractive surgery) in either eye.
6. Zonular laxity/dehiscence, pseudoexfoliation with clinically significant zonulopathy, nystagmus, or strabismus that could compromise uncomplicated surgery or reliable visual testing.
7. Participation in another clinical study (interventional) that could interfere with study results.
8. Planned monovision/mini-monovision or desire for monovision targeting.
9. Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders) per investigator judgment.
10. Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide reliable self-assessments.
11. Any active ocular infection or inflammation.

Where it's running

• Berkeley Eye Center - Sugar Land
  Sugar Land, Texas, United States Recruiting

Study contacts

• Study coordinator: Tetiana Huff
• Email: tetiana.huff@berkeleyeye.com
• Phone: 713-620-7640

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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.