Clareon TruPlus Intraocular Lens Outcomes in 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, single-site observational study evaluating Clareon TruPlus intraocular lenses in adults with age-related cataracts. It involves two surgeons performing procedures and collects refractive outcomes, visual acuity, and responses to the IOLSAT questionnaire up to 3 months post-operatively. The study does not randomize treatments or have a control arm. Eligible participants are adults over 40 with good preoperative visual potential and refractive targets compatible with mild astigmatism, while excluding those with significant ocular comorbities or prior ocular surgery beyond minor lid procedures. Outcomes will inform real-world performance of Clareon TruPlus lenses in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Willing and able to understand and sign informed consent.
* Adult patients (\>40 years old) undergoing age-related cataract surgery with expected best-corrected visual outcomes of 20/25 or better in both eyes pre-operatively as determined by surgeon and with regular corneal astigmatism correctable to less than 0.75 diopters post-operatively with no more than a T6 toric power IOL.
* Normal ocular findings aside from cataract and mild dry eye.

Exclusion Criteria:

* Subjects targeted for monovision.
* 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, amblyopia, zonular laxity or dehiscence, pseudoexfoliation.
* Previous history of any ocular surgery including LASIK (excluding minor lid procedures).
* Patients with irregular astigmatism/topography, corneal dystrophies, and pupil abnormalities.
* Participation in another clinical study that could interfere with the results.
* Any active ocular infection or inflammation.

Where it's running

• Ovo Lasik + Lens
  Saint Louis Park, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Martha Whiting, MD — OVO Lasik and Lens LLC
• Study coordinator: Ashley Prepeluh
• Email: ashley.prepeluh@ovoeye.com
• Phone: 952-204-5060

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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.