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
Berkeley Eye Center · with Sengi · NCT06922084
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 40+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 4
- Target enrollment
- 320
- US sites recruiting
- 2
- Study start
- March 17, 2025
- Record last updated
- September 30, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Clareon PanOptix; Clareon PanOptix PRO; Mix-and-Match PanOptix/Vivity
Conditions: Cataract
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Shafer Vision Institute
Plymouth Meeting, PA 19462
Site contact: Ailinn Dunn · ailinn@shafervision.com
Berkeley Eye Center
Houston, TX 77027
Site contact: Tetiana Huff · 713-620-7640 · tetiana.huff@berkeleyeye.com
Study contacts (from the official record)
- Tetiana Huff · 713-620-7640 · tetiana.huff@berkeleyeye.com
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