Recruiting

Clareon TruPlus IOL

Sponsor:

Laser Defined Vision

Code:

NCT07610226

Conditions

Cataract

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clareon TruPlus

Study Details

Brief summary:

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

Conditions

Cataract

Study ID

NCT07610226

Start date

Jun 25, 2026

Status verified date

Jul, 2026

Completion date

Jun 23, 2027

Anticipated

Primary completion date

Jun 23, 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 (>45 years old) undergoing age-related cataract surgery that previously had myopic corneal refractive surgery.
  • Dominant eye targeted for emmetropia, non-dominant eye may be targeted for ≤-0.75D (mini-monovision).
  • Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon.
  • Normal ocular findings aside from cataract.

Exclusion Criteria:

  • 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, zonular laxity or dehiscence, pseudoexfoliation.
  • Previous history of any ocular surgery, except for myopic LASIK or PRK.
  • Previous hyperopic refractive surgery.
  • Corneal HOA ≥1.0 µm (RMS) with OPD at 4mm scan.
  • Any active ocular infection or inflammation.

Study Design

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Arms

Clareon TruPlus

Interventions

Clareon TruPlus

Clareon TruPlus

Primary outcome measure

  • Binocular photopic BCDVA (4m) [ Time Frame: 3 months postoperatively ]

Central Contacts and Locations

Locations

Physicians Protocol

Recruiting

Greensboro, North Carolina, United States, 27401

Contacts

Carrie Williams

336-288-8823ldv2020@gmail.com

Principal Investigator:

Karl Stonecipher, MD

More Information

Sponsor

Laser Defined Vision

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Laser Defined Vision on 2026-07-23.