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RecruitingNCT07610226Updated Jul 23, 2026

Post-refractive IOL Outcomes With Clareon TruPlus

An observational study in Cataract, sponsored by Laser Defined Vision. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Laser Defined Vision · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cataract

Browse trials for

03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 35 is below the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Laser Defined Vision is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Willing and able to understand and sign .
  • 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (estimated)

Groups and cohorts

  • Clareon TruPlus

    Device: Clareon TruPlus

Interventions

  • DeviceClareon TruPlus

    Clareon TruPlus

06

What researchers measure

Primary outcomes

  1. Binocular photopic BCDVA (4m)

    Measured using standard ETDRS charts and recorded in logMAR

    Time frame: 3 months postoperatively

Secondary outcomes

  1. Binocular photopic DCIVA (66cm)

    Measured using standard ETDRS charts and recorded in logMAR

    Time frame: 3 months postoperatively

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

    Measured using standard ETDRS charts and recorded in logMAR

    Time frame: 3 months postoperatively

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

    Measured using standard ETDRS charts and recorded in logMAR

    Time frame: 3 months postoperatively

  4. 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

    Time frame: 3 months postoperatively

  5. Refractive outcomes

    sphere, cylinder, MRSE

    Time frame: 3 months postoperatively

Other outcomes

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

    Measured using standard ETDRS charts and recorded in logMAR

    Time frame: 3 months postoperatively

  2. Binocular photopic low contrast (25%) BCDVA

    Measured using standard ETDRS charts and recorded in logMAR

    Time frame: 3 months postoperatively

  3. 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.

    Time frame: 3 months postoperatively

07

Study locations

1 of 1 sites recruiting
  • Physicians Protocol
    Greensboro, North Carolina 27401, United States
    Recruiting
    • Carrie Williams · Contactldv2020@gmail.com · 336-288-8823
    • Karl Stonecipher, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jun 2027, 11 months after the start.

Of 167 non-industry observational studies under Cataract, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's planned 11 months is below that.

Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2026
First posted
May 27, 2026
StartActual
Jun 25, 2026
Primary completionEst.
Jun 23, 2027
CompletionEst.
Jun 23, 2027
Last update
Jul 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07610226
Lead sponsor
Laser Defined Vision
Collaborators
Sengi
Responsible party
Sponsor
First posted
May 27, 2026
Start date
Jun 25, 2026
Primary completion
Jun 23, 2027 (estimated)
Completion
Jun 23, 2027 (estimated)
Last update
Jul 23, 2026

Study contacts

Karl Stonecipher, MD
principal investigator · Physicians Protocol

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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