Phase
Condition
Vision Loss
Eye Disorders/infections
Eye Disease
Treatment
Clareon monofocal Intraocular lens (toric and non-toric models)
Clinical Study ID
Ages > 45 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes.
Adult cataract surgical patients over the age of 45 with visually significantbilateral cataracts (glare visual acuity 20/40 or worse with BCVA testing), withplanned cataract extraction using phacoemulsification, clear corneal incision andClareon monofocal or Clareon toric with Monarch IV.
Able to provide written informed consent for participation in the study.
All eyes will be in the range of availability for Clareon monofocal and Clareontoric with Monarch IV.
Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.
Exclusion
Exclusion Criteria:
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
Visually significant co-morbidities (corneal, retina, optic nerve disease) thatcould affect their satisfaction with surgery.
History of neovascular AMD, diabetic macular edema, unstable proliferative diabeticretinopathy, geographic atrophy, branch retinal artery or branch retinal veinocclusion, central retinal artery or central retinal vein occlusion, moderate tosevere epiretinal membrane, severe dry eye.
History of intraocular infection including HSV keratitis, VZV keratitis,endophthalmitis.
History of previous ocular surgery, including corneal refractive surgery, eye traumaor retinal detachment surgery.
History of rheumatoid arthritis, ocular cicatricial pemphigoid, or Steven's JohnsonSyndrome.
History of glaucoma.
The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Study Design
Study Description
Connect with a study center
Eye Consultants of Atlanta
Atlanta, Georgia 30339
United StatesSite Not Available

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