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RecruitingNCT07648355Updated Jun 15, 2026

Visual and Patient Reported Outcomes With Clareon TruPlus

An observational study in Cataract, sponsored by OVO LASIK + Lens. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by OVO LASIK + Lens · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)

Groups and cohorts

  • Clareon TruPlus

    Device: Clareon TruPlus

Interventions

  • DeviceClareon TruPlus

    Clareon TruPlus

05

What researchers measure

Primary outcomes

  1. Binocular photopic DCIVA

    Measured using a standardized ETDRS chart at 66cm.

    Time frame: 3 months postoperatively

Secondary outcomes

  1. Binocular photopic CDVA

    Measured using a standardized ETDRS chart at 4m.

    Time frame: 3 months postoperatively

Other outcomes

  1. Binocular photopic DCNVA

    Measured using a standardized ETDRS chart at 40cm.

    Time frame: 3 months postoperatively

  2. Binocular uncorrected distance visual acuity UDVA (4m)

    Measured using a standardized ETDRS charts

    Time frame: 3 months postoperatively

  3. Binocular photopic uncorrected intermediate visual acuity UIVA (66cm)

    Measured using a standardized ETDRS charts

    Time frame: 3 months postoperatively

  4. Binocular photopic uncorrected near visual acuity UNVA (40cm)

    Measured using a standardized ETDRS charts

    Time frame: 3 months postoperatively

  5. Monocular photopic uncorrected distance visual acuity UDVA (4m)

    Measured using a standardized ETDRS charts

    Time frame: 3 months postoperatively

  6. Monocular photopic uncorrected intermediate visual acuity UIVA (66cm)

    Measured using a standardized ETDRS charts

    Time frame: 3 months postoperatively

  7. Monocular photopic uncorrected near visual acuity UNVA (40cm)

    Measured using a standardized ETDRS charts

    Time frame: 3 months postoperatively

  8. Monocular photopic corrected distance visual acuity CDVA (4m)

    Measured using a standardized ETDRS charts

    Time frame: 3 months postoperatively

  9. Monocular photopic distance corrected intermediate visual acuity DCIVA (66cm)

    Measured using a standardized ETDRS charts

    Time frame: 3 months postoperatively

  10. Monocular photopic distance corrected near visual acuity DCNVA (40cm)

    Measured using a standardized ETDRS charts

    Time frame: 3 months postoperatively

  11. Monocular defocus curve

    Measured using a standardized ETDRS chart

    Time frame: 3 months postoperatively

  12. Refractive outcomes

    sphere and cylinder will be combined to determine MRSE (sphere + cylinder/2) = MRSE

    Time frame: 3 months postoperatively

  13. Satisfaction questionniar

    The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher satisfaction.

    Time frame: 3 months postoperatively

06

Study locations

1 of 1 sites recruiting
  • Ovo Lasik + Lens
    Saint Louis Park, Minnesota 55416, United States
    • Ashley Prepeluh · Contact · ashley.prepeluh@ovoeye.com · 952-204-5060
    • Martha F Whiting, MD · Principal investigator
    • Mark C Lobanoff, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07648355
Lead sponsor
OVO LASIK + Lens
Collaborators
Sengi
Responsible party
Sponsor
First posted
Jun 15, 2026
Start date
Jun 2, 2026
Primary completion
Jul 11, 2027 (estimated)
Completion
Jul 11, 2027 (estimated)
Last update
Jun 15, 2026

Study contacts

Ashley Prepeluh
Contact
ashley.prepeluh@ovoeye.com
952-204-5060
Martha Whiting, MD
principal investigator · OVO Lasik and Lens LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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