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NCT Number: NCT07658040

Clareon TruPlus vs Tecnis Eyhance IOLs in Cataract Patients

This study is a prospective, randomized, two-arm, single-center, single-surgeon, double-masked (subject and assessor) comparative study. It involves bilateral implantation of intraocular lenses (IOLs), comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in normal cataract patients. The study will be conducted at one site and will include a pre-operative visit and a 3-month post-operative assessment.

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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

North Georgia Eye Associates

Gainesville, Georgia, 30501, United States

Location contact

Clayton Blehm, MD

PRINCIPAL_INVESTIGATOR

Maryann Thomas

CONTACT

[email protected]

770-532-4444

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 patient diagnosed with age-related cataracts bilaterally.
  • Planned bilateral cataract removal and with bilateral implantation of the Clareon TruPlus IOL/Toric BLF (T3-T5) or Tecnis Eyhance IOL/Eyhance Toric (equivalent to T3-T5).
  • Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon.
  • Residual astigmatism expected to be <= 0.50 diopters in both eyes postoperatively as determined by surgeon (After using either toric IOL or arcuate incision with laser or manual LRI).
  • Normal ocular findings aside from cataract.

Exclusion criteria

  • Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
  • Previous history of any ocular surgery including corneal refractive surgery.
  • History of amblyopia or monofixation syndrome with poor stereoscopic vision.
  • Participants desiring monovision.
  • Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs).
  • Participation in another clinical study that could interfere with the results.
  • Any active ocular infection or inflammation.

Treatment and study plan

Clareon TruPlus

Device

Bilateral implantation

Tecnis Eyhance

Device

Bilateral implantation

Primary outcomes

  1. Binocular corrected distance visual acuity (CDVA)

    Time frame: 3 months postoperatively

Secondary outcomes

  1. Binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm

    Time frame: 3 months postoperatively

  2. Binocular uncorrected distance visual acuity (UDVA)

    Time frame: 3 months postoperatively

Other outcomes

  1. Monocular photopic BCDVA with pinhole

    Time frame: 3 months postoperatively

    dominant eye only, dilated with cyclopentolate 1%

  2. Binocular AULCSF (area under the log contrast sensitivity function) under photopic conditions without glare

    Time frame: 3 months postoperatively

  3. Binocular photopic DCNVA (40cm)

    Time frame: 3 months postoperatively

  4. Binocular photopic UDVA

    Time frame: 3 months postoperatively

  5. Binocular photopic UIVA (66cm)

    Time frame: 3 months postoperatively

  6. Binocular mesopic BCDVA

    Time frame: 3 months postoperatively

  7. Binocular mesopic DCIVA (66cm)

    Time frame: 3 months postoperatively

  8. Binocular mesopic DCIVA (66cm)

    Time frame: 3 months postoperatively

    Monocular distance corrected defocus curve (dominant eye)

  9. Binocular AULCSF (area under the log contrast sensitivity function) under mesopic conditions

    Time frame: 3 months postoperatively

  10. Pupil size (in mm)

    Time frame: 3 months postoperatively

    Measured with a pupilometer

  11. Manifest Refraction (in diopters)

    Time frame: 3 months postoperatively

  12. Visual disturbances questionnaire

    Time frame: 3 months postoperatively

    Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.

  13. Satisfaction questionnaire

    Time frame: 3 months postoperatively

    The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Maryann Thomas

CONTACT

[email protected]

770-532-4444

Sponsors and collaborators

Lead sponsor

Gainesville Eye Associates

Other

Collaborators

  • Sengi

Registry information

Official study title

Visual and Patient Reported Outcomes Comparing Clareon TruPlus IOL and Tecnis Eyhance IOLs in Normal Cataract Patients: Stage 1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Jun 18, 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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