Clareon TruPlus IOL in Post-Refractive Cataract Patients

This study is looking at how well the Clareon TruPlus lens (IOL) works in people who have had cataract surgery and also had previous eye surgery to correct their vision (refractive surgery). Researchers want to see how clear your vision is after getting this lens. To join, you must be an adult over 45 years old, have cataracts, and have had previous myopic (nearsighted) corneal refractive surgery. The study will measure your binocular photopic BCDVA (how well you see with both eyes in bright light) at 3 months after surgery to see if the lens is successful. The current status of this study is unclear.

Study design
This is an observational study with 35 participants, meaning researchers will observe outcomes without assigning different treatments. It is a single-arm study, meaning all participants will receive the Clareon TruPlus IOL.
What's involved
You would be assessed up to 3 months after your surgery. This includes clinical evaluations, visual acuity tests, and completing a questionnaire.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for up to 3 months after your surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07610226

Post-refractive IOL Outcomes With Clareon TruPlus

Recruiting
Not specifiedAges 18+Observational
Laser Defined Vision
~35 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Clareon TruPlus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Binocular photopic BCDVA (4m)
Measured over 3 months postoperatively
Cataract
1 sites across 1 states
North Carolina1
  • Karl Stonecipher, MD · PRINCIPAL_INVESTIGATOR · Physicians Protocol

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
  • Binocular photopic BCDVA (4m)3 months postoperatively

    Measured using standard ETDRS charts and recorded in logMAR