Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

Study Overview
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Brief Summary
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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 determine binocular intermediate vision. Patients will be assessed for corrected binocular distance and intermediate vision.

Detailed Description
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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) at the time of uncomplicated cataract surgery. These patients will then be assessed post-operatively to determine binocular intermediate vision. Patients will be assessed for corrected binocular distance and intermediate vision at plano for the Eyhance group and -0.25D for Clareon group.

Official Title
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Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

Conditions
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Pseudophakia

Intervention / Treatment
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* Diagnostic Test: Visual Acuity
* Diagnostic Test: Defocus Curve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, 40 years of age having already undergone uncomplicated cataract removal by phacoemulsification with a clear corneal incision in both eyes. Implantation of bilateral Clareon intraocular lenses or Eyhance intraocular lenses (DIB00/DIU***). Able to comprehend and willing to sign informed consent and complete all required testing procedures Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better Clear intraocular media Minimum of two weeks post yttrium aluminum garnet laser capsulotomy to treat PCO Exclusion Criteria: 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 Any complication during cataract surgery (capsular tear, vitrectomy, etc) 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) Amblyopia or strabismus in either eye History of or current anterior or posterior segment inflammation of any etiology Any form of neovascularization on or within the eye Glaucoma (uncontrolled or controlled with medication) Optic nerve atrophy Subjects with diagnosed degenerative eye disorders Postoperative CDVA worse than 0.10 logMAR (20/25 snellen) in either eye. 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. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clareon IOL Group<br>Patients with bilateral implantation of Clareon IOLs. | Diagnostic Test: Visual Acuity<br>* Measurement of distance and intermediate visual acuity at variety targeted correction.<br>Diagnostic Test: Defocus Curve<br>* Measurement of a defocus curve<br>|
| Eyhance IOL Group<br>Patients with bilateral implantation of EyhanceIOLs. | Diagnostic Test: Visual Acuity<br>* Measurement of distance and intermediate visual acuity at variety targeted correction.<br>Diagnostic Test: Defocus Curve<br>* Measurement of a defocus curve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance target-corrected binocular intermediate (66 cm) visual acuity | Distance target-corrected binocular intermediate (66 cm) visual acuity of Clareon subjects at -0.25 sphere and the Eyhance subjects plano sphere. | minimum of 3 weeks post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular target corrected defocus curve | Binocular target corrected defocus curve | minimum of 3 weeks post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eyhance, Clareon, pseudophakia