RecruitingPhase 4NCT06922084

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

Sponsor

Berkeley Eye Center

Enrollment

320 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Cataract

Summary

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.

Eligibility

Min Age: 40 Years

Inclusion Criteria6

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 Criteria11

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.