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NCT Number: NCT07610226

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Physicians Protocol

Greensboro, North Carolina, 27401, United States

Location status: Recruiting

Location contact

Carrie Williams

CONTACT

[email protected]

336-288-8823

Karl Stonecipher, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clareon TruPlus

Device

Clareon TruPlus

Primary outcomes

  1. Binocular photopic BCDVA (4m)

    Time frame: 3 months postoperatively

    Measured using standard ETDRS charts and recorded in logMAR

Secondary outcomes

  1. Binocular photopic DCIVA (66cm)

    Time frame: 3 months postoperatively

    Measured using standard ETDRS charts and recorded in logMAR

  2. Binocular photopic UDVA (4m), UIVA (66cm)

    Time frame: 3 months postoperatively

    Measured using standard ETDRS charts and recorded in logMAR

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

    Time frame: 3 months postoperatively

    Measured using standard ETDRS charts and recorded in logMAR

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

    Time frame: 3 months postoperatively

    Measured using standard ETDRS charts and recorded in logMAR

  5. Refractive outcomes

    Time frame: 3 months postoperatively

    sphere, cylinder, MRSE

Other outcomes

  1. Binocular mesopic BCDVA (4m), DCIVA (66cm)

    Time frame: 3 months postoperatively

    Measured using standard ETDRS charts and recorded in logMAR

  2. Binocular photopic low contrast (25%) BCDVA

    Time frame: 3 months postoperatively

    Measured using standard ETDRS charts and recorded in logMAR

  3. Rate of spectacle independence on the PRSIQ questionnaire

    Time frame: 3 months postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Laser Defined Vision

Other

Collaborators

  • Sengi

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 27, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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