Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07589894

Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus Intraocular Lens (IOL)

This study aims to generate data that characterizes visual outcomes, including the binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm or defocus behavior, of the Clareon TruPlus modified monofocal intraocular lens (IOL).

Clareon TruPlus IOL is designed to provide an extended range of vision compared to the parent monofocal IOL. Clareon TruPlus IOL delivers excellent intermediate vision without compromising distance vision including the quality of vision with low incidence of visual disturbances in normal cataract patients.

Binocular distance-corrected intermediate visual acuity at 66cm will be assessed at a pre-specified postoperative interval 12 weeks after second eye surgery. This study hypothesizes that Clareon TruPlus IOL delivers good binocular DCIVA at 66cm 12 weeks after second eye surgery.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Colvard-Kandavel Eye Center

Encino, California, 91316, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able and willing to understand and sign informed consent.
  • Able and willing to complete all required study visits.
  • Diagnosed with age-related cataracts in both eyes (OU)
  • Bilateral age-related cataract scheduled for phacoemulsification in both eyes by a single surgeon.
  • Surgeon predicts postoperative best corrected distance visual acuity (BCDVA) of ≥ 20/25 or better with Manifest Refractive Spherical Equivalent (MRSE) ±0.50 D of plano and in each eye post-operatively.
  • Clear intraocular media aside from cataract.
  • Will receive TruPlus bilaterally
  • Postoperative residual astigmatism ≤ 0.75 D in both eyes.
  • Refractive target: Emmetropia OU
  • Patient groups agreeing to either Femtosecond Laser Assisted Cataract Surgery (FLACS) or Standard phaco

Exclusion criteria

  • Ocular comorbidities affecting visual outcomes, including but not limited to:
  • Macular disease (e.g., Age-Related Macular Degeneration [AMD], Diabetic Macular Edema [DME], Epiretinal Membrane [ERM]).
  • Active ocular inflammation.
  • Any investigator-determined condition likely to confound postoperative visual performance.
  • Strabismus with or without amblyopia in either eye.
  • Prior anterior or posterior segment surgery, including corneal refractive procedures.
  • History of retinal detachment.
  • Degenerative retinal or visual disorders deemed clinically significant by the investigator.
  • Diagnosed glaucoma (of any stage, if deemed vision-impacting by investigator).
  • Systemic conditions that could affect healing or study outcomes (e.g., immunocompromised, connective tissue disease, clinically significant atopy, diabetes).

Treatment and study plan

Clareon TruPlus IOL

Device

A prospective, single-site, observational study evaluating binocular and monocular distance-corrected and uncorrected visual performance following bilateral implantation of the TruPlus intraocular lens (IOL). Both eyes will be targeted for emmetropia using Argos biometry with IOL power calculated by the Barrett Universal formula. Second-eye surgery will occur within 2 weeks of the first eye. Final evaluation will take place 12 weeks after second eye surgery.

Primary outcomes

  1. Binocular distance-corrected intermediate visual acuity (DCIVA) and Logarithm of the Minimum Angle of Resolution (logMAR) at 66cm at 12 weeks after second eye surgery

    Time frame: Baseline and 12 weeks after second eye surgery

Secondary outcomes

  1. Monocular and Binocular Best Distance Corrected Visual Acuity (BDCVA)

    Time frame: Baseline and 12 weeks after second eye surgery

  2. Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m, Uncorrected Intermediate Visual Acuity (UCIVA) at 66cm

    Time frame: Baseline and 12 weeks after second eye surgery

  3. Monocular DCIVA at 66cm

    Time frame: Baseline and 12 weeks after second eye surgery

  4. Monocular and Binocular distance corrected Defocus curve (at 3m) from +1.00D to -2.50D

    Time frame: Baseline and 12 weeks after second eye surgery

Sponsors and collaborators

Lead sponsor

Colvard Kandavel Eye Center

Other

Registry information

Official study title

BMVDI Study: Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus IOL

Acronym: BMVDI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 26, 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.

Published trials that share one or more normalized conditions with this study.