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CompletedNCT05226884Updated Nov 15, 2024Results posted

Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

An observational study in Pseudophakia, sponsored by Berkeley Eye Center. Completed at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-15.

Sponsored by Berkeley Eye Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
310
Ages
40 Years and older
Sex
All
01

Study summary

Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.

Read the detailed description

This is a non-interventional prospective, comparative study of the outcomes for patients following successful, uncomplicated cataract surgery. All patients will have had bilateral implantation of an Eyhance IOL (DIB00/DIU***) or Clareon IOL (CNA0T0) at the time of uncomplicated cataract surgery. These patients will then be assessed post-operatively to compare distance and intermediate visual acuities and a defocus curve in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.

Patients will be assessed for corrected binocular distance and intermediate vision.

02

Conditions studied

  • Pseudophakia

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Keywords

  • Clareon
  • Eyhance
  • pseudophakia
03

In context

Pseudophakia

54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.

This study's enrollment of 310 is above the median of 71 across 26 observational studies indexed under Pseudophakia.

Browse Pseudophakia studies →

Lead sponsor

Berkeley Eye Center is the lead sponsor of 8 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
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with healthy eyes and uncomplicated bilateral implantation of Eyhance intraocular lenses or Clareon intraocular lenses.

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

  1. Adults, 40 years of age having already undergone uncomplicated cataract removal by phacoemulsification with a clear corneal incision in both eyes.
  2. Implantation of bilateral Clareon intraocular lenses or Eyhance intraocular lenses (DIB00/DIU***).
  3. Able to comprehend and willing to sign and complete all required testing procedures
  4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
  5. Clear intraocular media
  6. Minimum of two weeks post yttrium aluminum garnet laser capsulotomy to treat PCO

Exclusion criteria

Exclusion Criteria:

  1. Any corneal abnormality, other than regular corneal astigmatism (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
  2. Any complication during cataract surgery (capsular tear, vitrectomy, etc)
  3. History of or current retinal conditions in either eye that would confound the results of this investigation in the opinion of the investigator (e.g. retinal detachment, epiretinal membrane, retinal ischemia, retinal inflammation, etc)
  4. Amblyopia or strabismus in either eye
  5. History of or current anterior or posterior segment inflammation of any etiology
  6. Any form of neovascularization on or within the eye
  7. Glaucoma (uncontrolled or controlled with medication)
  8. Optic nerve atrophy
  9. Subjects with diagnosed degenerative eye disorders
  10. Postoperative CDVA worse than 0.10 logMAR (20/25 snellen) in either eye.
  11. Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the investigator (e.g. , connective tissue disease, atopic disease, etc)
Terms in these criteria, in plain language(3)

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.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
310 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Clareon IOL Group

    Patients with bilateral implantation of Clareon IOLs.

    Diagnostic Test: Visual Acuity · Diagnostic Test: Defocus Curve

  • Eyhance IOL Group

    Patients with bilateral implantation of EyhanceIOLs.

    Diagnostic Test: Visual Acuity · Diagnostic Test: Defocus Curve

Interventions

  • Diagnostic testVisual Acuity

    Measurement of distance and intermediate visual acuity at variety targeted correction.

  • Diagnostic testDefocus Curve

    Measurement of a defocus curve

06

What researchers measure

Primary outcomes

  1. Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset

    Target-corrected binocular intermediate (66 cm) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.

    Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years

  2. Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity

    Distance corrected binocular intermediate visual acuity (measured at 66 cm) of Clareon subjects versus Eyhance subjects with both groups set at plano sphere. Non-inferiority defined as 1 line.

    Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years

  3. Non-inferiority of Best Corrected Distance Visual Acuity

    Comparison of Best Corrected Distance Visual Acuity (measured at 4m) of Clareon subjects versus Eyhance subjects.

    Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years

  4. Binocular Distance Corrected Defocus Curve

    The Binocular Distance Corrected Defocus Curve measures visual acuity across simulated distances (+1.0D to -3.0D) in subjects with intraocular lenses (IOLs) post-cataract surgery. Testing begins with the best corrected visual acuity (BCVA), and the patient's refractive error is entered into the phoropter as the 0 position. Defocus lenses are introduced in 0.5D increments to simulate various distances. Visual acuity is measured binocularly at each level using standardized charts (e.g., ETDRS, Snellen) and recorded in logMAR. Measurements are taken at least 3 months post-op under standardized lighting conditions to evaluate visual performance across the defocus range in IOL patients.

    Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years

  5. Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset

    Target-corrected binocular distance (4 m) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.

    Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years

Secondary outcomes

  1. Post-operative Spherical Equivalent

    Comparison of the Post-operative Spherical Equivalent of Clareon subjects versus Eyhance subjects.

    Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years

  2. Postoperative Residual Astigmatism

    Comparison of the amount of residual astigmatism of Clareon subjects versus Eyhance subjects.

    Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years

07

Results

Posted Nov 15, 2024
Limitations and caveats
As this was a study on subjects who had already undergone cataract surgery, pre-operative targeting was not controlled for and based on patient discussions (e.g. mini-monovision, monovision, emmetropia). However, measuring visual acuities with distance correction allowed for a head-to-head comparison without residual postoperative refractive error as a confounding factor. Another potential limitation was that Eyhance torics were included, but the Clareon toric was not available.

Participant flow

Participant flow — Overall Study
MilestoneClareon IOL GroupEyhance IOL Group
Started155155
Completed155155
Not completed00

Outcome measures

PrimaryNon-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset

Target-corrected binocular intermediate (66 cm) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.

Time frame:
Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Reported as:
Mean · LogMAR
Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset
LogMARClareon IOL GroupEyhance IOL Group
Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset0.20 ± 0.10.19 ± 0.11
Statistical analysis
  • Clareon IOL Group vs Eyhance IOL Group · Wilcoxon (Mann-Whitney) · p = <0.05Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.
PrimaryNon-inferiority of Distance Corrected Binocular Intermediate Visual Acuity

Distance corrected binocular intermediate visual acuity (measured at 66 cm) of Clareon subjects versus Eyhance subjects with both groups set at plano sphere. Non-inferiority defined as 1 line.

Time frame:
Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Reported as:
Mean · LogMAR
Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity
LogMARClareon IOL GroupEyhance IOL Group
Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity0.24 ± 0.110.19 ± 0.11
Statistical analysis
  • Clareon IOL Group vs Eyhance IOL Group · Wilcoxon (Mann-Whitney) · p = <0.05Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.
PrimaryNon-inferiority of Best Corrected Distance Visual Acuity

Comparison of Best Corrected Distance Visual Acuity (measured at 4m) of Clareon subjects versus Eyhance subjects.

Time frame:
Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Reported as:
Mean · LogMAR
Non-inferiority of Best Corrected Distance Visual Acuity
LogMARClareon IOL GroupEyhance IOL Group
Non-inferiority of Best Corrected Distance Visual Acuity0.01 ± 0.020.02 ± 0.03
Statistical analysis
  • Clareon IOL Group vs Eyhance IOL Group · Wilcoxon (Mann-Whitney) · p = <0.05Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.
PrimaryBinocular Distance Corrected Defocus Curve

The Binocular Distance Corrected Defocus Curve measures visual acuity across simulated distances (+1.0D to -3.0D) in subjects with intraocular lenses (IOLs) post-cataract surgery. Testing begins with the best corrected visual acuity (BCVA), and the patient's refractive error is entered into the phoropter as the 0 position. Defocus lenses are introduced in 0.5D increments to simulate various distances. Visual acuity is measured binocularly at each level using standardized charts (e.g., ETDRS, Snellen) and recorded in logMAR. Measurements are taken at least 3 months post-op under standardized lighting conditions to evaluate visual performance across the defocus range in IOL patients.

Time frame:
Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Reported as:
Mean · LogMAR
Binocular Distance Corrected Defocus Curve
LogMARClareon IOL GroupEyhance IOL Group
-3.0 D0.75 ± 0.170.74 ± 0.17
-2.5 D0.6 ± 0.170.58 ± 0.16
-2.0 D0.46 ± 0.160.44 ± 0.15
-1.5 D0.31 ± 0.130.29 ± 0.14
-1.0 D0.19 ± 0.110.16 ± 0.11
-0.5 D0.08 ± 0.070.07 ± 0.07
-0.25 D0.03 ± .050.03 ± .05
0 D0.01 ± .020.02 ± .03
0.25 D0.05 ± .060.07 ± 0.07
0.5 D0.14 ± .080.16 ± .1
1 D0.31 ± .120.31 ± .11
Statistical analysis
  • Clareon IOL Group vs Eyhance IOL Group ·
PrimaryNon-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset

Target-corrected binocular distance (4 m) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.

Time frame:
Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Reported as:
Mean · LogMAR
Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset
LogMARClareon IOL GroupEyhance IOL Group
Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset0.03 ± 0.020.02 ± 0.03
Statistical analysis
  • Clareon IOL Group vs Eyhance IOL Group · Wilcoxon (Mann-Whitney) · p = <0.05Normality was assumed if skewness was ±2 and kurtosis was ±7. Non-inferiority was confirmed before further statistical testing.
SecondaryPost-operative Spherical Equivalent

Comparison of the Post-operative Spherical Equivalent of Clareon subjects versus Eyhance subjects.

Time frame:
Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Reported as:
Mean · Diopters
Post-operative Spherical Equivalent
DioptersClareon IOL GroupEyhance IOL Group
Post-operative Spherical Equivalent-0.04 ± 0.51-0.04 ± 0.73
SecondaryPostoperative Residual Astigmatism

Comparison of the amount of residual astigmatism of Clareon subjects versus Eyhance subjects.

Time frame:
Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Reported as:
Mean · Diopters
Postoperative Residual Astigmatism
DioptersClareon IOL GroupEyhance IOL Group
Postoperative Residual Astigmatism0.43 ± 0.440.36 ± 0.36

Adverse events

Collected over Single (1 hour) visit. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Clareon IOL Group0/155 (0%)0/155 (0%)0/155 (0%)
Eyhance IOL Group0/155 (0%)0/155 (0%)0/155 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Clareon IOL GroupEyhance IOL GroupTotal
Mean69.26 ± 6.6169.54 ± 6.8569.45 ± 6.73
Sex: Female, Male
Sex: Female, Male(Participants)Clareon IOL GroupEyhance IOL GroupTotal
Female10085185
Male5570125
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Clareon IOL GroupEyhance IOL GroupTotal
American Indian or Alaska Native011
Asian639
Native Hawaiian or Other Pacific Islander112
Black or African American521668
White94134228
More than one race202
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Clareon IOL GroupEyhance IOL GroupTotal
United States155155310
Axial Length
Axial Length(millimeters)Clareon IOL GroupEyhance IOL GroupTotal
Mean23.81 ± 1.0724.27 ± 1.4124.04 ± 1.24
IOL Power
IOL Power(Diopters)Clareon IOL GroupEyhance IOL GroupTotal
Mean20.52 ± 2.8619.77 ± 4.0120.15 ± 3.44
Corneal Astigmatism
Corneal Astigmatism(diopters)Clareon IOL GroupEyhance IOL GroupTotal
Mean43.48 ± 1.4943.08 ± 1.8543.28 ± 1.67
Anterior Chamber Depth
Anterior Chamber Depth(millimeters)Clareon IOL GroupEyhance IOL GroupTotal
Mean3.13 ± 0.393.23 ± 0.393.18 ± 0.39

4 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Berkeley Eye Center
    Houston, Texas 77027, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05226884
Lead sponsor
Berkeley Eye Center
Responsible party
Sponsor
First posted
Feb 7, 2022
Start date
Nov 30, 2021
Primary completion
Aug 6, 2022
Completion
Aug 6, 2022
Results posted
Nov 15, 2024
Last update
Nov 15, 2024

Study contacts

Morgan Micheletti, MD
principal investigator · Berkeley Eye Center

Oversight

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

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