NCT06922084 · Berkeley Eye Center
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
What this study is about
forward-looking, randomly assigned, conducted at multiple hospitals, multi-treatment group$1, subject and vision-assessor-masked, two stage study with Stage 1 as a three-treatment group$1 initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.
View original scientific description
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.
Interventions
DEVICE
Clareon PanOptix
Bilateral Clareon PanOptix IOL implantation
DRUG
Clareon PanOptix PRO
Bilateral Clareon PanOptix PRO IOL implantation
DRUG
Mix-and-Match PanOptix/Vivity
Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye
Primary outcome measures
Binocular photopic CDVA (corrected distance visual acuity)
Time frame: 3 months postoperatively
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 di
Where
- Plymouth Meeting, Pennsylvania
- Houston, Texas
Collaborators
Sengi
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 10, 2025 · Source of record for eligibility and locations