Actively Recruiting
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
Led by Berkeley Eye Center · Updated on 2025-04-10
320
Participants Needed
2
Research Sites
54 weeks
Total Duration
On this page
Sponsors
B
Berkeley Eye Center
Lead Sponsor
S
Sengi
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Adults 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
- Postoperative potential visual acuity of 20/25 or better in each eye
- Preoperative corneal astigmatism correctable with T3 or T4 toric IOL, or spherical IOL with LRIs or AKs resulting in predicted postoperative astigmatism less than 0.5 diopters
- Ability to understand and complete questionnaires
You will not qualify if you...
- Women who are pregnant, planning pregnancy, or breastfeeding
- Ocular conditions that could affect study results including moderate to severe corneal pathology, irregular astigmatism, moderate to severe dry eye, macular degeneration, diabetic retinopathy
- Any confirmed glaucomatous damage
- Participation in another clinical study that could interfere with results
- Systemic conditions affecting healing or vision outcomes such as uncontrolled diabetes or certain autoimmune disorders
- Nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation
- Prior ocular surgery except uncomplicated cataract surgery in the fellow eye
- Desire for monovision
- Active ocular infection or inflammation except routine post-operative inflammation in fellow eye
- Psychiatric or cognitive disorders impairing compliance or self-assessment
- RMS total higher-order aberrations greater than 0.70 µm or coma greater than 0.40 µm measured by tomography or topography with 4 mm pupil setting
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here