Phase
Condition
Eye Disorders/infections
Vision Loss
Eye Disease
Treatment
enVista Aspire EA or Aspire Toric ETA IOLs
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
22 years of age or older on the date the Informed Consent Form (ICF) is signed.
Subjects must be capable of understanding and providing informed consent on theInstitutional Review Board (IRB)- approved Informed Consent Form (ICF) andauthorization as appropriate for local privacy regulations.
Have a BCDVA at or worse than 20/40 in each eye, with or without a glare source, dueto a clinically significant cataract (cortical, nuclear, subcapsular, orcombination) that is considered amenable to treatment with standardphacoemulsification cataract extraction and capsular IOL implantation.
Have a BCDVA projected to be better than 20/30 after IOL implantation in each eye asdetermined by the medical judgment of the Principal Investigator.
Subjects must have clear intraocular media other than the cataract in both eyes.
Subjects must require an IOL power from +6.0 diopter (D) to +34.0 diopter (D) inboth eyes.
Subjects with clinically significant preoperative corneal astigmatism must requirean IOL toric power between 1.25 diopter (D) to 5.75 diopter (D).
Subjects must be willing and able to comply with all treatment and follow-upClinical Investigation visits and procedures
Exclusion
Exclusion Criteria:
Pre-existing ocular conditions (subjects with prior corneal refractive surgery,irregular corneal astigmatism, severe (clinically significant) corneal dystrophy,e.g., Fuch's, macular disease, optic nerve atrophy, corneal endothelial disease,abnormal cornea, macular degeneration, retinal degeneration, and chronic drugmiosis, who may not achieve the visual acuity of patients without such problems,etc.)
Associated ocular conditions that could affect the stability of the IOL (e.g.,traumaticzonulolysis, zonular dialysis, evident zonular weakness or dehiscence,etc.) in the study eye.
Retinal conditions, or predisposition to retinal conditions, previous history of, ora predisposition to, retinal detachment or proliferative diabetic retinopathy, inwhich future treatment may be compromised by implanting this IOL
Amblyopia
Rubella, congenital, traumatic, or complicated cataracts
Extremely shallow anterior chamber, not due to swollen cataract
Recurrent anterior or posterior segment inflammation of unknown etiology, or anydisease producing an inflammatory reaction (e.g., iritis or uveitis)
Aniridia
Iris neovascularization
Subjects who have uncontrolled glaucoma in either eye. Uncontrolled glaucoma isdefined as intraocular pressure (IOP) greater than 21 mm Hg in spite of maximallytolerated medications (with more than three topical drugs for IOP control).
Microphthalmos or macrophthalmos
Previous corneal transplant, prior YAG laser iridotomy, YAG vitreolysis, and priorphakic IOL insertions.
Pre-existing ocular conditions that may negatively impact the stability of theimplant or intraoperative conditions (posterior capsular rupture, complications inwhich the IOL stability could be compromised, inability to place IOL in capsularbag, etc.).
Mechanical or surgical manipulation required to enlarge the pupil
Vitreous loss (significant)
Anterior chamber bleeding (significant)
Study Design
Connect with a study center
Site 118
Birmingham, Alabama 35209
United StatesSite Not Available
Site 154
Bullhead City, Arizona 86442
United StatesSite Not Available
Site 137
Chandler, Arizona 85224
United StatesSite Not Available
Site 136
Mesa, Arizona 85202
United StatesSite Not Available
Site 162
Phoenix, Arizona 85028
United StatesSite Not Available
Site 105
Tucson, Arizona 85704
United StatesSite Not Available
Site 104
Bakersfield, California 93309
United StatesSite Not Available
Site 101
Beverly Hills, California 90210
United StatesSite Not Available
Site 151
Hemet, California 92543
United StatesSite Not Available
Site 111
Huntington Beach, California 92647
United StatesSite Not Available
Site 126
Long Beach, California 90805
United StatesSite Not Available
Site 149
Los Angeles, California 90024
United StatesSite Not Available
Site 155
Murrieta, California 92562
United StatesSite Not Available
Site 109
Newport Beach, California 92707
United StatesSite Not Available
Site 112
Orange, California 92868
United StatesSite Not Available
Site 144
Pasadena, California 91107
United StatesSite Not Available
Site 119
Torrance, California 90505
United StatesSite Not Available
Site 115
Upland, California 91786
United StatesSite Not Available
Site 161
Greenwich, Connecticut 06830
United StatesSite Not Available
Site 130
Milford, Connecticut 06460
United StatesSite Not Available
Site 164
Stamford, Connecticut 06902
United StatesSite Not Available
Site 125
Bradenton, Florida 34209
United StatesSite Not Available
Site 148
Mount Dora, Florida 32757
United StatesSite Not Available
Site 143
Pompano Beach, Florida 33064
United StatesSite Not Available
Site 127
Tarpon Springs, Florida 34689
United StatesSite Not Available
Site 153
Winter Park, Florida 32792
United StatesSite Not Available
Site134
Gainesville, Georgia 30501
United StatesSite Not Available
Site 165
Roswell, Georgia 30076
United StatesSite Not Available
Site 160
Honolulu, Hawaii 96814
United StatesSite Not Available
Site 163
Honolulu, Hawaii 96813
United StatesSite Not Available
Site 108
Rock Island, Illinois 61201
United StatesSite Not Available
Site 133
Shreveport, Louisiana 71103
United StatesSite Not Available
Site 116
Bowie, Maryland 20716
United StatesSite Not Available
Site 131
Birmingham, Michigan 48009
United StatesSite Not Available
Site 121
Alexandria, Minnesota 56308
United StatesSite Not Available
Site 142
Alexandria, Minnesota 56308
United StatesSite Not Available
Site 102
Bloomington, Minnesota 55420
United StatesSite Not Available
Site 106
Kansas City, Missouri 64133
United StatesSite Not Available
Site 128
Bozeman, Montana 59718
United StatesSite Not Available
Site 117
S. Sioux City, Nebraska 68776
United StatesSite Not Available
Site 114
South Orange, New Jersey 07079
United StatesSite Not Available
Site 159
Albuquerque, New Mexico 87109
United StatesSite Not Available
Site 120
New York, New York 10013
United StatesSite Not Available
Site132
Poughkeepsie, New York 12603
United StatesSite Not Available
Site 138
Goldsboro, North Carolina 27534
United StatesSite Not Available
Site 156
Leland, North Carolina 28451
United StatesSite Not Available
Site 107
W. Fargo, North Dakota 58078
United StatesSite Not Available
Site 103
Brecksville, Ohio 44142
United StatesSite Not Available
Site 129
Cincinnati, Ohio 45242
United StatesSite Not Available
Site 166
Moore, Oklahoma 73160
United StatesSite Not Available
Site 152
Bend, Oregon 97701
United StatesSite Not Available
Site 135
Medford, Oregon 97504
United StatesSite Not Available
Site 150
Allenwood, Pennsylvania 17810
United StatesSite Not Available
Site 140
Bala-Cynwyd, Pennsylvania 19004
United StatesSite Not Available
Site 157
Kingston, Pennsylvania 18704
United StatesSite Not Available
Site 145
Austin, Texas 78704
United StatesSite Not Available
Site 158
Austin, Texas 78731
United StatesSite Not Available
Site 113
Beaumont, Texas 77707
United StatesSite Not Available
Site 110
Dallas, Texas 75243
United StatesSite Not Available
Site 141
Houston, Texas 77055
United StatesSite Not Available
Site 147
Houston, Texas 77008
United StatesSite Not Available
Site 123
San Antonio, Texas 78209
United StatesSite Not Available
Site 124
San Antonio, Texas 78229
United StatesSite Not Available
Site 122
Salt Lake City, Utah 84107
United StatesSite Not Available
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