Visual Outcomes with PanOptix Pro and Clareon Vivity Lenses for Age-Related Cataracts
Clareon PanOptix Pro and Clareon Vivity Intraocular Lens
+ Clareon PanOptix Pro Intraocular Lenses
Cataract
+ Eye Diseases
+ Lens Diseases
Treatment Study
Summary
Study start date: August 5, 2025
Actual date on which the first participant was enrolled.This study aims to compare the visual results and patient satisfaction between two different types of lens implants for people with age-related cataracts in both eyes. One group receives a PanOptix Pro lens in one eye and a Clareon Vivity lens in the other, while the second group receives PanOptix Pro lenses in both eyes. The goal is to see if using different lenses in each eye can reduce visual disturbances like halos and improve overall satisfaction without compromising vision quality. This research is important as it could lead to better cataract surgery outcomes for patients by finding the optimal combination of lenses to improve vision. Participants in this study undergo cataract surgery, which involves removing the cloudy lens from each eye and replacing it with a clear artificial lens. The surgeries are done a few weeks apart, and the vision is tested at various distances both before and after the procedure. The study measures outcomes like distance vision, near vision, and how well participants can see in low-light conditions. The study also collects information about any visual disturbances and overall satisfaction with the implants. Participants are kept unaware of which lenses they receive to ensure unbiased results. Any potential adverse effects are monitored closely to ensure participant safety throughout the trial.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.346 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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).
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Vance Thompson Vision
Alexandria, United StatesVance Thompson Vision
Bozeman, United StatesMain Line Surgery Center
Bala-Cynwyd, United States