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

Berkeley Eye Center

Status and phase: Enrolling; Phase 4

Conditions: Cataract

Treatments: Drug: Clareon PanOptix PRO; Device: Clareon PanOptix; Drug: Mix-and-Match PanOptix/Vivity

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06922084

95474481

Details and patient eligibility

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 3 patient groups

Bilateral Clareon PanOptix IOL implantation

Active Comparator group

Treatment:

Device: Clareon PanOptix

Bilateral Clareon PanOptix Pro IOL implantation

Experimental group

Treatment:

Drug: Clareon PanOptix PRO

Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye

Experimental group

Treatment:

Drug: Mix-and-Match PanOptix/Vivity