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
| NCT ID | NCT06922084 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Berkeley Eye Center |
| Condition | Cataract |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 320 participants in total. It began in 2025-03-17 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Morgan Micheletti, MD
PRINCIPAL INVESTIGATOR
Berkeley Eye Center
Frequently Asked Questions
Who can join the NCT06922084 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06922084 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06922084 currently recruiting?
Yes, NCT06922084 is actively recruiting participants. Contact the research team at tetiana.huff@berkeleyeye.com for enrollment information.
Where is the NCT06922084 trial being conducted?
This trial is being conducted at Plymouth Meeting, United States, Houston, United States.
Who is sponsoring the NCT06922084 clinical trial?
NCT06922084 is sponsored by Berkeley Eye Center. The principal investigator is Morgan Micheletti, MD at Berkeley Eye Center. The trial plans to enroll 320 participants.