Post-refractive IOL Outcomes With Clareon TruPlus

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Clareon TruPlus

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Recruiting
      • Physicians Protocol
      • Contact: Carrie Williams; Phone Number: 336-288-8823; Email: ldv2020@gmail.com
      • Principal Investigator: Karl Stonecipher, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clareon TruPlus	Device: Clareon TruPlus; Clareon TruPlus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular photopic BCDVA (4m)	Measured using standard ETDRS charts and recorded in logMAR	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular photopic DCIVA (66cm)	Measured using standard ETDRS charts and recorded in logMAR	3 months postoperatively
Binocular photopic UDVA (4m), UIVA (66cm)	Measured using standard ETDRS charts and recorded in logMAR	3 months postoperatively
Monocular photopic BCDVA (4m), DCIVA (66cm) in dominant and non-dominant eye	Measured using standard ETDRS charts and recorded in logMAR	3 months postoperatively
Binocular distance corrected defocus curve (+1.00 to -2.00 in 0.50D, +0.50 to -0.50 in 0.25D)	Measured using standard ETDRS charts and recorded in logMAR	3 months postoperatively
Refractive outcomes	sphere, cylinder, MRSE	3 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular mesopic BCDVA (4m), DCIVA (66cm)	Measured using standard ETDRS charts and recorded in logMAR	3 months postoperatively
Binocular photopic low contrast (25%) BCDVA	Measured using standard ETDRS charts and recorded in logMAR	3 months postoperatively
Rate of spectacle independence on the PRSIQ questionnaire	Participants are asked to indicate spectacle usage on a scale of "All of the time" to "None of the time" for distance, intermediate, and near vision.	3 months postoperatively

Collaborators and Investigators

• Sponsor: Laser Defined Vision
• Collaborators: Sengi
• Investigators: Principal Investigator: Karl Stonecipher, MD, Physicians Protocol

Study record dates

Study Major Dates

• Study Start (Estimated): June 23, 2026
• Primary Completion (Estimated): June 23, 2027
• Study Completion (Estimated): June 23, 2027

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: KS-26-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes