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
RecruitingPhase 4Healthy volunteers welcome
Who can join
Ages 40 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
About the study
Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.
What is being tested
- Clareon PanOptix (device)
- Clareon PanOptix PRO (drug)
- Mix-and-Match PanOptix/Vivity (drug)
Sponsor: Berkeley Eye Center · Participants: 320 · Started: Mar 17, 2025
Contact the study team
- Tetiana Huff · Phone: 713-620-7640
Official record on ClinicalTrials.gov — NCT06922084
Locations in the U.S.
| Pennsylvania | Shafer Vision Institute, Plymouth Meeting |
| Texas | Berkeley Eye Center, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.