Recruiting

Clareon TruPlus IOL

Sponsor:

OVO LASIK + Lens

Code:

NCT07648355

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clareon TruPlus

Study Details

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.

Conditions

Cataract

Study ID

NCT07648355

Start date

Jun 2, 2026

Status verified date

Jun, 2026

Completion date

Jul 11, 2027

Anticipated

Primary completion date

Jul 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Clareon TruPlus

Interventions

Clareon TruPlus

Clareon TruPlus

Primary outcome measure

  • Binocular photopic DCIVA [ Time Frame: 3 months postoperatively ]

Central Contacts and Locations

Central contacts

Ashley Prepeluh

952-204-5060ashley.prepeluh@ovoeye.com

Locations

Ovo Lasik + Lens

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Ashley Prepeluh

952-204-5060ashley.prepeluh@ovoeye.com

Principal Investigator:

Martha F Whiting, MD

More Information

Sponsor

OVO LASIK + Lens

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OVO LASIK + Lens on 2026-06-15.