Post-refractive IOL Outcomes With Clareon TruPlus

NCT07610226 | Recruiting FDA Device

• 1 other identifier: KS-26-01
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Binocular photopic BCDVA (4m)

  Measured using standard ETDRS charts and recorded in logMAR

  3 months postoperatively

Secondary Outcomes (5)

• Binocular photopic DCIVA (66cm)

  3 months postoperatively

• Binocular photopic UDVA (4m), UIVA (66cm)

  3 months postoperatively

• Monocular photopic BCDVA (4m), DCIVA (66cm) in dominant and non-dominant eye

  3 months postoperatively

• Binocular distance corrected defocus curve (+1.00 to -2.00 in 0.50D, +0.50 to -0.50 in 0.25D)

  3 months postoperatively

• Refractive outcomes

  3 months postoperatively

Other Outcomes (3)

• Binocular mesopic BCDVA (4m), DCIVA (66cm)

  3 months postoperatively

• Binocular photopic low contrast (25%) BCDVA

  3 months postoperatively

• Rate of spectacle independence on the PRSIQ questionnaire

  3 months postoperatively

Study Arms (1)

Clareon TruPlus

Device: Clareon TruPlus

Interventions

Clareon TruPlus DEVICE

Clareon TruPlus

Clareon TruPlus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

35 adults over 45 years old undergoing cataract surgery post-myopic corneal refractive surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laser Defined Vision: lead
• Sengi: collaborator

Study Sites (1)

Physicians Protocol

Greensboro, North Carolina, 27401, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Karl Stonecipher, MD

  Physicians Protocol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): June 23, 2026
• Primary Completion (Estimated): June 23, 2027
• Study Completion (Estimated): June 23, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)