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

April 3, 2025 updated by: Berkeley Eye Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Recruiting
        • Shafer Vision Institute
        • Contact:
        • Principal Investigator:
          • Brian Shafer
    • Texas
      • Houston, Texas, United States, 77027
        • Recruiting
        • Berkeley Eye Center
        • Principal Investigator:
          • Morgan Micheletti, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Bilateral Clareon PanOptix IOL implantation
Device: Clareon PanOptix
Bilateral Clareon PanOptix IOL implantation
Experimental: Bilateral Clareon PanOptix Pro IOL implantation
Drug: Clareon PanOptix PRO
Bilateral Clareon PanOptix PRO IOL implantation
Experimental: Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye
Drug: Mix-and-Match PanOptix/Vivity
Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Binocular photopic CDVA (corrected distance visual acuity)
Time Frame: 3 months postoperatively
3 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity)
Time Frame: 3 months postoperatively
3 months postoperatively
Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA)
Time Frame: 3 months postoperatively
3 months postoperatively
Binocular photopic small letter contrast sensitivity at 66 cm and 100 cm with refractive distance correction (20/32 line)
Time Frame: 3 months postoperatively
3 months postoperatively
Binocular mesopic high contrast distance corrected visual acuity at distance (CDVA), intermediate (DCIVA), and near (DCNVA).
Time Frame: 3 months postoperatively
3 months postoperatively
Binocular photopic distance corrected defocus curve
Time Frame: 3 months postoperatively
Obtained by varying the vergence of the stimulus from -3.0 D to +1.0 D in steps of 0.5 D with the best correction for distance vision.
3 months postoperatively
Monocular photopic distance corrected defocus curves
Time Frame: 3 months postoperatively
Obtained by varying the vergence of the stimulus from -3.0 D to +1.0 D in steps of 0.5 D with the best correction for distance vision.
3 months postoperatively
Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd)
Time Frame: 3 months postoperatively
3 months postoperatively
Refractive outcomes
Time Frame: 3 months postoperatively
Mean residual manifest refraction spherical equivalent (MRSE) and residual astigmatism.
3 months postoperatively
Pupil size
Time Frame: 3 months postoperatively
Under both photopic and mesopic conditions.
3 months postoperatively
Patient-reported outcomes using a questionnaire about visual disturbances (QUVID)
Time Frame: 3 months postoperatively
3 months postoperatively
Patient-reported outcomes using a questionnaire about IOL satisfaction (IOLSAT)
Time Frame: 3 months postoperatively
3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Berkeley Eye Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sengi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Morgan Micheletti, MD, Berkeley Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 95474481

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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