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RecruitingNCT07658040Updated Sep 1, 2026

Clareon TruPlus vs Tecnis Eyhance IOLs in Cataract Patients

An observational study in Cataract, sponsored by Gainesville Eye Associates. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Gainesville Eye Associates · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
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Study summary

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.

02

Conditions studied

  • Cataract

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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 70 is below the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Gainesville Eye Associates is the lead sponsor of 10 studies on the registry; 3 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

Adult patients with bilateral age-related cataracts eligible for planned bilateral cataract removal and IOL implantation.

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 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

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.
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
70 participants (estimated)

Groups and cohorts

  • Clareon TruPlus

    Device: Clareon TruPlus

  • Tecnis Eyhance

    Device: Tecnis Eyhance

Interventions

  • DeviceClareon TruPlus

    Bilateral implantation

  • DeviceTecnis Eyhance

    Bilateral implantation

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What researchers measure

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

    dominant eye only, dilated with cyclopentolate 1%

    Time frame: 3 months postoperatively

  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)

    Monocular distance corrected defocus curve (dominant eye)

    Time frame: 3 months postoperatively

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

    Time frame: 3 months postoperatively

  10. Pupil size (in mm)

    Measured with a pupilometer

    Time frame: 3 months postoperatively

  11. Manifest Refraction (in diopters)

    Time frame: 3 months postoperatively

  12. Visual disturbances questionnaire

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

    Time frame: 3 months postoperatively

  13. Satisfaction questionnaire

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

    Time frame: 3 months postoperatively

07

Study locations

1 of 1 sites recruiting
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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 Jul 2026 (actual). Primary completion is estimated for Aug 2027, 12 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 12 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
Jun 10, 2026
First posted
Jun 18, 2026
StartActual
Jul 20, 2026
Primary completionEst.
Aug 9, 2027
CompletionEst.
Aug 9, 2027
Last update
Sep 1, 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 Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07658040
Lead sponsor
Gainesville Eye Associates
Collaborators
Sengi
Responsible party
Sponsor
First posted
Jun 18, 2026
Start date
Jul 20, 2026
Primary completion
Aug 9, 2027 (estimated)
Completion
Aug 9, 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

Maryann Thomas
Contact
maryann.thomas@ngeye.com
770-532-4444
Clayton Blehm, MD
principal investigator · North Georgia Eye Associates

Oversight

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

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