Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

Berkeley Eye Center

Status

Completed

Conditions

Pseudophakia

Treatments

Diagnostic Test: Defocus Curve

Diagnostic Test: Visual Acuity

Study type

Observational

Funder types

Other

Identifiers

NCT05226884

69901155

Details and patient eligibility

About

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

Full 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.

Enrollment

310 patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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)