Visual and Patient Reported Outcomes With Clareon TruPlus

June 9, 2026 updated by: OVO LASIK + Lens

Visual and Patient Reported Outcomes of Clareon TruPlus IOL in Cataract Surgery Patients

This is a prospective, single-site, two-surgeon, single-arm, observational study evaluating the Clareon TruPlus IOL. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the IOLSAT Questionnaire.

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.
Observational

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.
40

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
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Ovo Lasik + Lens
        • Principal Investigator:
          • Mark C Lobanoff, MD
        • Contact:
        • Principal Investigator:
          • Martha F Whiting, MD

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

No

Sampling Method

Non-Probability Sample

Study Population

Adults over 40 years undergoing age-related cataract surgery with expected visual outcomes of 20/25 or better.

Description

Inclusion Criteria:

  • Willing and able to understand and sign informed consent.
  • Adult patients (>40 years old) undergoing age-related cataract surgery with expected best-corrected visual outcomes of 20/25 or better in both eyes pre-operatively as determined by surgeon and with regular corneal astigmatism correctable to less than 0.75 diopters post-operatively with no more than a T6 toric power IOL.
  • Normal ocular findings aside from cataract and mild dry eye.

Exclusion Criteria:

  • Subjects targeted for monovision.
  • Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, amblyopia, zonular laxity or dehiscence, pseudoexfoliation.
  • Previous history of any ocular surgery including LASIK (excluding minor lid procedures).
  • Patients with irregular astigmatism/topography, corneal dystrophies, and pupil abnormalities.
  • Participation in another clinical study that could interfere with the results.
  • Any active ocular infection or inflammation.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Clareon TruPlus
Device: Clareon TruPlus
Clareon TruPlus

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
Measure Description
Time Frame
Binocular photopic DCIVA
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS chart at 66cm.
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 CDVA
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS chart at 4m.
3 months postoperatively

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Binocular photopic DCNVA
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS chart at 40cm.
3 months postoperatively
Binocular uncorrected distance visual acuity UDVA (4m)
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS charts
3 months postoperatively
Binocular photopic uncorrected intermediate visual acuity UIVA (66cm)
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS charts
3 months postoperatively
Binocular photopic uncorrected near visual acuity UNVA (40cm)
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS charts
3 months postoperatively
Monocular photopic uncorrected distance visual acuity UDVA (4m)
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS charts
3 months postoperatively
Monocular photopic uncorrected intermediate visual acuity UIVA (66cm)
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS charts
3 months postoperatively
Monocular photopic uncorrected near visual acuity UNVA (40cm)
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS charts
3 months postoperatively
Monocular photopic corrected distance visual acuity CDVA (4m)
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS charts
3 months postoperatively
Monocular photopic distance corrected intermediate visual acuity DCIVA (66cm)
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS charts
3 months postoperatively
Monocular photopic distance corrected near visual acuity DCNVA (40cm)
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS charts
3 months postoperatively
Monocular defocus curve
Time Frame: 3 months postoperatively
Measured using a standardized ETDRS chart
3 months postoperatively
Refractive outcomes
Time Frame: 3 months postoperatively
sphere and cylinder will be combined to determine MRSE (sphere + cylinder/2) = MRSE
3 months postoperatively
Satisfaction questionniar
Time Frame: 3 months postoperatively
The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher satisfaction.
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.
OVO LASIK + Lens

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: Martha Whiting, MD, OVO Lasik and Lens LLC

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.
June 2, 2026

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.
July 11, 2027

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.
July 11, 2027

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).
June 4, 2026

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.
June 9, 2026

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.
June 15, 2026

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.
June 15, 2026

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.
June 9, 2026

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.
June 1, 2026

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.
  • MW-26-01

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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