Phase
Condition
Eye Disorders/infections
Eye Disease
Vision Loss
Treatment
Cataract extraction with phacoemulsification comparing two systems
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy patients 18 years or older undergoing uncomplicated sequential bilateralcataract surgery with phacoemulsification and IOL implantation
Expected to undergo sequential cataract surgery in both eyes
Must have bilateral nuclear sclerosis cataracts classified using LOCS III as grade 3or above (see appendix III)
Both eyes will be operated on by the same surgeon
Have the ability to consent for study and procedure planned
Exclusion
Exclusion Criteria:
Patients under 18 years of age.
Complex cataract cases involving zonulopathy (e.g., pseudoexfoliation syndrome,traumatic zonular weakness) that may require use of zonular support devices duringsurgery (e.g. capsular hooks) and/or implantation of capsular tension rings or otherzonular support devices, and in the investigator's judgment, may interfere with thesurgical procedure or study outcome measures.
Require mechanical pupil expanding devices (e.g., iris hooks, Malyugin rings, etc.)
Undergoing femtosecond laser-assisted lens fragmentation.
Surgical complications, in the opinion of the investigator, occurring eitherintraoperatively or postoperatively (including capsule tears, iris trauma, ordecentered intraocular lens) and not attributable to the study device or studydesign.
Prior ocular surgery (including intraocular, oculoplastic, corneal or refractivesurgical procedure) performed within the last 3 months or at any time that in theinvestigator's clinical judgment, if it interferes with the outcome measures of thisstudy.
Presence of endothelial cell dystrophies and/or corneal comorbidities.
History of intraocular inflammation (e.g., uveitis, iritis).
History of retinal edema or presence of a clinically significant epiretinal membranethat, in the investigator's clinical judgment, may interfere with the outcomemeasures of this study.
History of retinal surgery (e.g.retinal detachment repair, membrane peel) involvingvitrectomy.
Dense brunescent cataract that in the investigator's clinical judgment, mayinterfere with the outcome measures of this study.
Study Design
Study Description
Connect with a study center
Advanced Vision Care
Los Angeles, California 90067
United StatesActive - Recruiting

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