Visual and Patient Reported Outcomes With Clareon TruPlus

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07648355

Enrollment

Registered

2026-06-15

Start date

2026-06-02

Completion date

2027-07-11

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

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.

Interventions

DEVICEClareon TruPlus

Clareon TruPlus

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

CONTACTAshley Prepeluh

ashley.prepeluh@ovoeye.com952-204-5060

PRINCIPAL_INVESTIGATORMartha Whiting, MD

OVO Lasik and Lens LLC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026