Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

Completed

Conditions: Pseudophakia

Interventions: Diagnostic Test: Visual Acuity
Diagnostic Test: Defocus Curve

Registration Number: NCT05226884

Lead Sponsor: Berkeley Eye Center

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 310

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)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eyhance IOL Group	Visual Acuity	Patients with bilateral implantation of EyhanceIOLs.
Clareon IOL Group	Defocus Curve	Patients with bilateral implantation of Clareon IOLs.
Eyhance IOL Group	Defocus Curve	Patients with bilateral implantation of EyhanceIOLs.
Clareon IOL Group	Visual Acuity	Patients with bilateral implantation of Clareon IOLs.

Primary Outcome Measures

Name	Time	Method
Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	Target-corrected binocular intermediate (66 cm) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	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.
Non-inferiority of Best Corrected Distance Visual Acuity	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	Comparison of Best Corrected Distance Visual Acuity (measured at 4m) of Clareon subjects versus Eyhance subjects.
Binocular Distance Corrected Defocus Curve	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	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.
Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	Target-corrected binocular distance (4 m) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.

Secondary Outcome Measures

Name	Time	Method
Postoperative Residual Astigmatism	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	Comparison of the amount of residual astigmatism of Clareon subjects versus Eyhance subjects.
Post-operative Spherical Equivalent	Minimum of 3 months post-operatively from cataract surgery, up to 2 years	Comparison of the Post-operative Spherical Equivalent of Clareon subjects versus Eyhance subjects.