Actively Recruiting
Comparing Bilateral Clareon PanOptix, Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Adults With Cataracts
Led by Berkeley Eye Center · Updated on 2025-04-10
320
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Berkeley Eye Center
Lead Sponsor
S
Sengi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, randomized, multicenter study to compare three types of intraocular lens (IOL) implantations in adults with cataracts aged 40 years and older. The study is designed with two stages: an initial three-arm enrollment followed by a head-to-head comparison based on data from the first stage. The trial evaluates vision outcomes after cataract surgery using different Clareon lenses to better understand their effects on visual acuity and patient satisfaction. The study involves three treatment groups: bilateral Clareon PanOptix IOL implantation, bilateral Clareon PanOptix Pro IOL implantation, and a mixed approach with Clareon PanOptix Pro in one eye and Clareon Vivity in the other. Participants will receive their assigned lens implantations during cataract surgery. The study is masked so that subjects and vision assessors do not know which lenses are implanted to ensure unbiased evaluation. Participants will be monitored for at least three months after surgery, during which several visual acuity measurements will be taken, including corrected distance, intermediate, and near vision under different lighting conditions. Patient-reported outcomes about visual disturbances and satisfaction with the lenses will be collected through questionnaires. The study also measures contrast sensitivity, refractive outcomes, and pupil size. Safety and vision improvements will be regularly assessed throughout the follow-up period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo intraocular lens implantation surgery and receive immediate post-operative care.
1 surgery visit and approximately 1 post-operative visit
Duration - Up to 3 months
Participants attend follow-up visits to assess visual acuity and recovery after surgery.
Multiple follow-up visits over 3 months
Trial Site Locations
Total: 2 locations
1
Shafer Vision Institute
Plymouth Meeting, Pennsylvania, United States, 19462
Actively Recruiting
2
Berkeley Eye Center
Houston, Texas, United States, 77027
Actively Recruiting
Research Team
T
Tetiana Huff
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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