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

Launched by BERKELEY EYE CENTER · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying different types of intraocular lenses (IOLs) used in cataract surgery. Specifically, it compares three types: the Clareon PanOptix, Clareon PanOptix Pro, and a combination of Clareon PanOptix Pro and Vivity lenses. The goal is to find out which lens provides the best vision after surgery. The trial is open to adults aged 40 and older who are scheduled for cataract surgery in both eyes and are expected to have good vision post-surgery.

If you decide to participate, you will need to attend several scheduled visits for assessments and complete questionnaires about your vision. It's important to know that not everyone can join; for example, you should not have any serious eye conditions, be pregnant, or have had major eye surgery before. The study aims to gather information from multiple centers, making it a significant step in understanding how different lenses affect vision after cataract surgery.

Gender

ALL

Eligibility criteria

• 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 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.