Visual Outcomes in Patients Contralaterally Implanted With PanOptix Pro and Clareon Vivity Compared to Bilateral Implantation of PanOptix Pro
Launched by BRIAN SHAFER · Jul 14, 2025
Trial Information
Current as of July 25, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well two different types of lens implants work for people having cataract surgery. Cataracts cause cloudy vision, and during surgery, the cloudy lens is replaced with an artificial one called an intraocular lens (IOL). This study compares patients who receive two different lenses—PanOptix Pro in one eye and Clareon Vivity in the other—with those who get the PanOptix Pro lens in both eyes. The goal is to see if the mix of lenses provides vision just as good for distance and if it causes fewer visual side effects like halos or glare around lights.
Adults with cataracts in both eyes who are planning to have cataract surgery in both eyes may be eligible. To join, patients should expect good vision after surgery (about 20/25 or better) and have only mild astigmatism (a small imperfection in the eye’s shape). People with other eye problems, previous eye surgeries, or certain conditions like severe dry eye or glaucoma won’t qualify. Participants will have surgery on each eye within about a month, followed by eye tests and questionnaires about their vision and satisfaction three months later. The study keeps both patients and doctors unaware of which lens was implanted in each eye to ensure fair results. This research aims to help doctors and patients choose the best lens options for clear, comfortable vision after cataract surgery.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria Adult patients (≥18 years old) able and willing to provide informed consent.
- • Bilateral diagnosis of age-related cataracts.
- Planned bilateral cataract removal by phacoemulsification with either:
- • Contralateral implantation of Clareon PanOptix Pro/PanOptix Pro Toric in one eye and Clareon Vivity/Vivity Toric in the fellow eye, or
- • Bilateral implantation of Clareon PanOptix Pro/PanOptix Pro Toric.
- • Expected best monocular corrected distance visual acuity (BCDVA) of 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively, as determined by the surgeon.
- • Residual astigmatism expected to be ≤0.50 diopters in both eyes postoperatively (using toric IOLs or arcuate incisions as needed).
- • Normal ocular findings aside from cataracts.
- • Exclusion Criteria Corneal pathology or irregular astigmatism.
- • Preexisting macular disease or other retinal degenerative disease expected to cause vision loss.
- • Glaucoma.
- • Severe dry eye disease.
- • Nystagmus or strabismus.
- • Zonular laxity or dehiscence, pseudoexfoliation.
- • Any condition (in the investigator's opinion) that may affect study endpoints.
- • Previous history of any ocular surgery, including corneal refractive surgery.
- • Subjects desiring monovision.
- • History of amblyopia or monofixation syndrome with poor stereoscopic vision.
- • Total corneal higher-order aberrations (HOA) greater than 0.6 microns.
- • Any planned simultaneous or combined procedures at the time of cataract surgery (e.g., MIGS).
- • Participation in another clinical study that could interfere with study results.
- • Any active ocular infection or inflammation.
- • Pregnant, breastfeeding, or planning to become pregnant during the study (as determined by verbal inquiry).
About Brian Shafer
Brian Shafer is a clinical trial sponsor with expertise in overseeing and managing research studies aimed at advancing medical knowledge and improving patient care. Committed to maintaining high standards of regulatory compliance and ethical conduct, Brian Shafer collaborates closely with research teams to ensure the successful execution of clinical trials from initiation through completion.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Alexandria, Minnesota, United States
Plymouth Meeting, Pennsylvania, United States
Baltimore, Maryland, United States
Bozeman, Montana, United States
Bala Cynwyd, Pennsylvania, United States
Patients applied
Trial Officials
Brian Shafer, MD
Principal Investigator
Shafer Vision Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported