Post-refractive IOL Outcomes With Clareon TruPlus in Cataract Patients

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, single-arm study at one center and surgeon to observe post-refractive cataract patients receiving the Clareon TruPlus IOL. Participants will be followed for up to 3 months after surgery, with assessments of refractive outcomes, visual acuity, and PRISQ questionnaire responses. The study aims to provide real-world data on visual performance and patient-reported experience after implantation of this IOL in eyes with prior myopic refractive procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Willing and able to understand and sign informed consent.
* Adult patients (\>45 years old) undergoing age-related cataract surgery that previously had myopic corneal refractive surgery.
* Dominant eye targeted for emmetropia, non-dominant eye may be targeted for ≤-0.75D (mini-monovision).
* Best monocular corrected distance visual acuity 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.

Exclusion Criteria:

* Moderate-severe 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, except for myopic LASIK or PRK.
* Previous hyperopic refractive surgery.
* Corneal HOA ≥1.0 µm (RMS) with OPD at 4mm scan.
* Any active ocular infection or inflammation.

Where it's running

• Physicians Protocol
  Greensboro, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Karl Stonecipher, MD — Physicians Protocol

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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.