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CataractBMVDINCT07589894

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

An observational study of Cataract and Cataract Surgery, run by Colvard Kandavel Eye Center at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Cataract, Cataract Surgery, Cataract Bilateral
What is being tested?
Clareon TruPlus IOL
Type of treatment
Medical device
How many people
50 participants
Where
1 siteUnited States
Study dates
May 2026to May 2027
How long will I take part?
4 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Colvard-Kandavel Eye Center patients with bilateral cataracts

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Colvard-Kandavel Eye Center

    Encino, California, 91316

Other trials in United States

About this study

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

Being tested
Clareon TruPlus IOL
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clareon TruPlus IOLDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and 12 weeks after second eye surgery

Secondary outcomes (4)

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

    Measured: Baseline and 12 weeks after second eye surgery

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

    Measured: Baseline and 12 weeks after second eye surgery

  3. Monocular DCIVA at 66cm

    Measured: Baseline and 12 weeks after second eye surgery

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

    Measured: Baseline and 12 weeks after second eye surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
Target duration
4 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07589894
Sponsor's protocol ID
BMVDI-102745323
Acronym
BMVDI
Status last verified
May 2026
First submitted
11 May 2026
Last updated
26 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Srinivasan S et al. Meta-analysis of Defocus Curves of Monofocal, Enhanced Monofocal, and EDoF IOLs. Giglio R, Tognetto D. Evaluation of an Enhanced Monofocal IOL Compared to Clareon Monofocal and Tecnis 1-Piece.

  • Tran E, Shah N, Caballero Ortiz S, Kyveris A, Berg G, Chan T. Visual Performance and Refractive Stability of Clareon(R) Monofocal Intraocular Lens Implanted with an Automated Delivery System. Clin Ophthalmol. 2025 Oct 24;19:3933-3939. doi: 10.2147/OPTH.S545977. eCollection 2025.

    PubMed 41164804

  • Blehm C. Visual Acuity Using a Defocus Curve and Refractive Stability in the Alcon Clareon IOL.

  • Micheletti JM, Duncan NB, Hall B. Head-to-Head Comparison of Intermediate Vision of Two Monofocal Intraocular Lenses. Clin Ophthalmol. 2023 Dec 21;17:3983-3990. doi: 10.2147/OPTH.S444696. eCollection 2023.

    PubMed 38146452

  • Beltraminelli T, Rizzato A, Toniolo K, Galli A, Menghini M. Comparison of visual performances of enhanced monofocal versus standard monofocal IOLs in a mini-monovision approach. BMC Ophthalmol. 2023 Apr 21;23(1):170. doi: 10.1186/s12886-023-02920-6.

    PubMed 37085852

  • Park MJ, Lee HS, Chang IB, Hong IH. Improved Intermediate Visual Function with New Monofocal Intraocular Lens in Combined Cataract and Vitrectomy Surgery for Retinal Disease. Korean J Ophthalmol. 2023 Oct;37(5):401-408. doi: 10.3341/kjo.2023.0056. Epub 2023 Aug 25.

    PubMed 37621091

  • Garzón, N., et al. Visual and optical quality of enhanced intermediate monofocal intraocular lenses. International Journal of Ophthalmology. 2022; 15(9): (description of the Tecnis® Eyhance ICB00 as having modified aspheric optics and improved intermediate vision with preserved distance visual acuity).

  • Auffarth, G. U., et al. Clinical evaluation of a new monofocal intraocular lens with enhanced intermediate function in cataract patients. Journal of Cataract & Refractive Surgery. 2021; 47(2): (results showing improved intermediate vision with Tecnis Eyhance and comparable distance outcomes).

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract and Cataract Surgery, run by Colvard Kandavel Eye Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07589894, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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