Visual and Patient Reported Outcomes With Clareon TruPlus

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: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Clareon TruPlus

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Ashley Prepeluh; Phone Number: 952-204-5060; Email: ashley.prepeluh@ovoeye.com

Study Locations

• United States
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Recruiting
      • Ovo Lasik + Lens
      • Principal Investigator: Mark C Lobanoff, MD
      • Contact: Ashley Prepeluh; Phone Number: 952-204-5060; Email: ashley.prepeluh@ovoeye.com
      • Principal Investigator: Martha F Whiting, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clareon TruPlus	Device: Clareon TruPlus; Clareon TruPlus

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular photopic DCNVA	Measured using a standardized ETDRS chart at 40cm.	3 months postoperatively
Binocular uncorrected distance visual acuity UDVA (4m)	Measured using a standardized ETDRS charts	3 months postoperatively
Binocular photopic uncorrected intermediate visual acuity UIVA (66cm)	Measured using a standardized ETDRS charts	3 months postoperatively
Binocular photopic uncorrected near visual acuity UNVA (40cm)	Measured using a standardized ETDRS charts	3 months postoperatively
Monocular photopic uncorrected distance visual acuity UDVA (4m)	Measured using a standardized ETDRS charts	3 months postoperatively
Monocular photopic uncorrected intermediate visual acuity UIVA (66cm)	Measured using a standardized ETDRS charts	3 months postoperatively
Monocular photopic uncorrected near visual acuity UNVA (40cm)	Measured using a standardized ETDRS charts	3 months postoperatively
Monocular photopic corrected distance visual acuity CDVA (4m)	Measured using a standardized ETDRS charts	3 months postoperatively
Monocular photopic distance corrected intermediate visual acuity DCIVA (66cm)	Measured using a standardized ETDRS charts	3 months postoperatively
Monocular photopic distance corrected near visual acuity DCNVA (40cm)	Measured using a standardized ETDRS charts	3 months postoperatively
Monocular defocus curve	Measured using a standardized ETDRS chart	3 months postoperatively
Refractive outcomes	sphere and cylinder will be combined to determine MRSE (sphere + cylinder/2) = MRSE	3 months postoperatively
Satisfaction questionniar	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher satisfaction.	3 months postoperatively

Collaborators and Investigators

• Sponsor: OVO LASIK + Lens
• Collaborators: Sengi
• Investigators: Principal Investigator: Martha Whiting, MD, OVO Lasik and Lens LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2026
• Primary Completion (Estimated): July 11, 2027
• Study Completion (Estimated): July 11, 2027

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID 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