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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bilateral Clareon PanOptix IOL implantation

Group Type ACTIVE_COMPARATOR

Clareon PanOptix

Intervention Type DEVICE

Bilateral Clareon PanOptix IOL implantation

Bilateral Clareon PanOptix Pro IOL implantation

Group Type EXPERIMENTAL

Clareon PanOptix PRO

Intervention Type DRUG

Bilateral Clareon PanOptix PRO IOL implantation

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

Group Type EXPERIMENTAL

Mix-and-Match PanOptix/Vivity

Intervention Type DRUG

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

Interventions

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Clareon PanOptix

Bilateral Clareon PanOptix IOL implantation

Intervention Type DEVICE

Clareon PanOptix PRO

Bilateral Clareon PanOptix PRO IOL implantation

Intervention Type DRUG

Mix-and-Match PanOptix/Vivity

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes