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Study Comparing Clareon PanOptix, PanOptix Pro, and Mixed Lenses for Cataracts

This study is looking at different types of intraocular lenses (IOLs) used during cataract surgery. It compares three options: the Clareon PanOptix lens, the Clareon PanOptix PRO lens, and a mix-and-match approach where you'd receive the Clareon PanOptix Pro in one eye and the Clareon Vivity in the other. The goal is to see how well people can see after surgery with these different lenses. You might be able to join if you are an adult aged 40 or older, need cataract surgery in both eyes, and are able to attend all study visits. The study aims to enroll 320 people. We don't have information on the current recruitment status.

Study design
This is a randomized study, meaning you would be assigned to one of the lens groups by chance. It is also 'masked,' so neither you nor the vision assessor will know which lens you received. The study plans to enroll 320 participants.
What's involved
You would need to attend all scheduled study visits as required by the protocol. The primary endpoint is measured at 3 months after surgery.
Compensation
Not stated in the trial record.
Follow-up
Your vision will be checked at 3 months after surgery as a primary measure.

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

NCT06922084

A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects

Recruiting
PHASE4Ages 40+InterventionalTreatment
Berkeley Eye Center
~320 participants
Updated 2025-04-10 on ClinicalTrials.gov
What's tested:Clareon PanOptixClareon PanOptix PROMix-and-Match PanOptix/Vivity

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Binocular photopic CDVA (corrected distance visual acuity)
Measured over 3 months postoperatively

Conditions

Cataract

Explore related trials

Cataract

Where it's being run

2 sites across 2 states
Pennsylvania1
Texas1

Study leadership

  • Morgan Micheletti, MD · PRINCIPAL_INVESTIGATOR · Berkeley Eye Center

Who to contact

Tetiana Huff
[email protected]
713-620-7640
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult cataract patients aged 40 years and older scheduled for age related cataract surgery in both eyes.
Ability to understand and sign an ethics committee-approved informed consent form.
Willingness and ability to attend all scheduled study visits as required by the protocol.
Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
Preoperative corneal astigmatism that can be corrected with a T3 or T4 toric IOL, or with a spherical IOL and LRIs or AKs resulting in a predicted postoperative astigmatism of less than 0.5 diopters (D).
Ability to understand and complete questionnaires.

Exclusion

Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
Ocular conditions that could confound study results, including moderate to severe corneal pathology, irregular astigmatism, moderate to severe dry eye, preexisting retinal diseases such as macular degeneration or diabetic retinopathy.
Any form of confirmed glaucomatous damage (ie, mild, moderate, or severe glaucoma).
Participation in another clinical study that could interfere with the results.
Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders).
Subjects with nystagmus, strabismus, zonular laxity or dehiscence, and pseudoexfoliation.
Prior ocular surgery (except for uncomplicated cataract surgery in the fellow eye).
Participants desiring monovision.
Any active ocular infection or inflammation (except for routine post-operative inflammation in the fellow eye)
Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide accurate self-assessments.
RMS total higher-order aberrations (HOAs) \>0.70 µm or coma \>0.40 µm as measured by tomography or topography with a 4 mm pupil setting.

What this trial measures

  • Binocular photopic CDVA (corrected distance visual acuity)3 months postoperatively