Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
Conditions: Pseudophakia
Sponsor: Berkeley Eye Center

 
 
 
 
 
 
 
 
 
 
 
 
 
Intermediate Vision in Patients with Clareon IOLs Compared to Eyhance IOLs 
NCT05226884 
17 Jan 2022 
 
 

PROTOCOL TITLE: Intermediate Vision in Patients with Clareon IOLs Compared to 
Eyhance IOLs 
PROTOCOL 
 BEC001-69901155, NCT05226884 
 Non-interventional (None). 
J. Morgan Micheletti, MD
Berkeley Eye Center, Houston, Texas 
STUDY TREATMENTS: 
Principal Investigator:          
Location:  
Background: 
The recently launched Eyhance IOL is a monofocal designed to slightly extend the depth of 
focus. 
Indications for use “TECNIS Eyhance IOL for the visual correction of aphakia in adult patients 
in whom a cataractous lens has been removed by extracapsular cataract extraction.” 
In two prior Vivity registration studies, the AcrySof IQ monofocal lens was used as the control 
lens and showed functional intermediate vision (~20/32) via binocular IVA measurement.    
Defocus curves also demonstrated a slightly extended depth of focus with the AcrySof IQ and 
mean visual acuities remained above 0.0 logMAR (20/20 Snellen) between +0.50D~-0.50D 
defocus.  
Clinical data is needed to determine if the Clareon monofocal IOLs can provide similar range of 
vision as the Eyhance monofocal IOLs. 
Clinical Hypothesis: 
Patients with bilateral Eyhance IOLs may have improvements in intermediate vision, however, it 
has previously been reported that bilateral Clareon IOLs also provide improved intermediate 
vision (see Vivity - Directions For Use). 
This study aims to determine the non-inferiority of bilateral Clareon IOLs compared to bilateral 
Eyhance IOLs at intermediate vision.  
Scientific Rationale: 
The Eyehance IOL was approved as a Level A Modification of the ZCB00 IOL, thus no clinical 
data was required for that approval.  The inference is that the Eyhance provides an extended 
range of vision due to the slight modification to the optic design 
Study Objectives: 
Compare distance and intermediate visual acuities and a defocus curve in patients with bilateral 
Clareon Monofocal IOLs versus bilateral Eyhance IOLs. 

OVERALL STUDY DESIGN 
This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, 
two-arm comparative study of the outcomes for patients following successful, uncomplicated 
cataract surgery. 155 subjects will be enrolled in each arm of the study, with 310 total subjects. 
All patients will have had bilateral implantation of an Eyhance IOL (DIB00/DIU***) or Clareon 
IOL (CNA0T0/CCA0T0) at the time of uncomplicated cataract surgery. These patients will then 
be assessed at least 3 months post-operatively. 
Duration: 
12 months or longer to meet required enrollment.  
Administration: 
Patients with healthy eyes and previously implanted Eyhance IOLs or Clareon IOLs will be 
offered the opportunity to participate in the study.  
Visit Schedule: 
All subjects will undergo 1 visit. At the study visit and after informed consent, the subjects’ 
demographic information will be collected, and the subject will have the following testing:  
1) Manifest refraction (both groups) 
2) Binocular corrected distance visual acuity (BDVA) at 4m (both groups) 
3) Distance corrected intermediate visual acuity (DCIVA) at 66 cm (both groups) 
4) Distance targeted-corrected binocular distance and intermediate visual acuity with 
+0.25D offset (Clareon group)  
5) Binocular distance corrected defocus curve from +1.0 D to -3.0 D at 0.5D steps, with 
0.25 D steps between -0.50 D and +0.50 D 
STUDY POPULATION CHARACTERISTICS: 
Condition 
Patients with healthy eyes and uncomplicated bilateral implantation of Eyhance IOLs or Clareon 
IOLs. 
Number of Subjects: 
Under the assumption that the difference between binocular targeted corrected intermediate 
visual acuity between the two arms is 0.05 logMAR, thus demonstrating non-inferiority, then 
155 patients per arm would be required, for a total of 310 patients. The standard deviation for 
each measurement is 0.15 logMAR, a power of 80% and Type I error probability of 0.05. 
Source: Kohn MA, Senyak J. Sample Size Calculators [website]. UCSF CTSI. 8 August 2021. 
Available at https://www.sample-size.net/ [Accessed 28 September 2021] 

Inclusion/Exclusion Criteria (all study criteria apply to each study eye unless otherwise 
indicated): 
Inclusions 
1) Adults, at least 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 IOLs or Eyhance IOLs (DIB00/DIU***).
3) Able to comprehend and willing to sign informed consent 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 YAG capsulotomy to treat PCO
7) Residual refractive astigmatism ≤0.75 diopters
8) Post op refractive results for the Clareon subjects are from 0.00 to -0.50 SE
9) Post op refractive results for the Eyhance subjects are from +0.25 to -0.25 SE
Exclusions 
Subjects will not be permitted to enroll in this study if they meet any of the following 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 or predisposition to retinal conditions
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 in either eye. 
11)  Subjects who have an acute or chronic disease or illness that would confound the results 
of this investigation (e.g. immunocompromised, connective tissue disease, clinically 
significant atopic disease, diabetes, etc) 
Outcome Measures: 
Primary Endpoints: 
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. 
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.  
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. 
4. Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset: 
Comparison of Best Corrected Distance Visual Acuity (measured at 4m) of Clareon 
subjects versus Eyhance subjects. 
5. Binocular Distance Corrected Defocus Curve: Comparison of the binocular distance 
corrected defocus curve of Clareon subjects versus Eyhance subjects from +1.0D to -
3.00D. 
Secondary Endpoints: 
1. Post-operative Spherical Equivalent 
2. Post-operative Residual Astigmatism 
Statistical Analysis  
Welch Two Sample t-test for parametric data and Wilcoxon rank-sum test for non-parametric 
data. Non-inferiority will be defined as within 0.1 LogMAR.