A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction
NCT ID: NCT06594185
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
335 participants
INTERVENTIONAL
2024-08-29
2025-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs
enVista Aspire EA or Aspire Toric ETA IOLs
enVista Aspire EA or Aspire Toric ETA IOLs
Interventions
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enVista Aspire EA or Aspire Toric ETA IOLs
enVista Aspire EA or Aspire Toric ETA IOLs
Eligibility Criteria
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Inclusion Criteria
2. Subjects must be capable of understanding and providing informed consent on the Institutional Review Board (IRB)- approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.
3. Have a BCDVA at or worse than 20/40 in each eye, with or without a glare source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation.
4. Have a BCDVA projected to be better than 20/30 after IOL implantation in each eye as determined by the medical judgment of the Principal Investigator.
5. Subjects must have clear intraocular media other than the cataract in both eyes.
6. Subjects must require an IOL power from +6.0 diopter (D) to +34.0 diopter (D) in both eyes.
7. Subjects with clinically significant preoperative corneal astigmatism must require an IOL toric power between 1.25 diopter (D) to 5.75 diopter (D).
8. Subjects must be willing and able to comply with all treatment and follow-up Clinical Investigation visits and procedures
Exclusion Criteria
2. 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.
3. Retinal conditions, or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or proliferative diabetic retinopathy, in which future treatment may be compromised by implanting this IOL
4. Amblyopia
5. Rubella, congenital, traumatic, or complicated cataracts
6. Extremely shallow anterior chamber, not due to swollen cataract
7. Recurrent anterior or posterior segment inflammation of unknown etiology, or any disease producing an inflammatory reaction (e.g., iritis or uveitis)
8. Aniridia
9. Iris neovascularization
10. Subjects who have uncontrolled glaucoma in either eye. Uncontrolled glaucoma is defined as intraocular pressure (IOP) greater than 21 mm Hg in spite of maximally tolerated medications (with more than three topical drugs for IOP control).
11. Microphthalmos or macrophthalmos
12. Previous corneal transplant, prior YAG laser iridotomy, YAG vitreolysis, and prior phakic IOL insertions.
13. Pre-existing ocular conditions that may negatively impact the stability of the implant or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc.).
14. Mechanical or surgical manipulation required to enlarge the pupil
15. Vitreous loss (significant)
16. Anterior chamber bleeding (significant)
22 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Locations
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Site 118
Birmingham, Alabama, United States
Site 154
Bullhead City, Arizona, United States
Site 137
Chandler, Arizona, United States
Site 136
Mesa, Arizona, United States
Site 162
Phoenix, Arizona, United States
Site 105
Tucson, Arizona, United States
Site 104
Bakersfield, California, United States
Site 101
Beverly Hills, California, United States
Site 151
Hemet, California, United States
Site 111
Huntington Beach, California, United States
Site 126
Long Beach, California, United States
Site 149
Los Angeles, California, United States
Site 155
Murrieta, California, United States
Site 109
Newport Beach, California, United States
Site 112
Orange, California, United States
Site 144
Pasadena, California, United States
Site 119
Torrance, California, United States
Site 115
Upland, California, United States
Site 161
Greenwich, Connecticut, United States
Site 130
Milford, Connecticut, United States
Site 164
Stamford, Connecticut, United States
Site 125
Bradenton, Florida, United States
Site 148
Mt. Dora, Florida, United States
Site 143
Pompano Beach, Florida, United States
Site 127
Tarpon Springs, Florida, United States
Site 153
Winter Park, Florida, United States
Site134
Gainesville, Georgia, United States
Site 165
Roswell, Georgia, United States
Site 163
Honolulu, Hawaii, United States
Site 160
Honolulu, Hawaii, United States
Site 108
Rock Island, Illinois, United States
Site 133
Shreveport, Louisiana, United States
Site 131
Birmingham, Michigan, United States
Site 121
Alexandria, Minnesota, United States
Site 142
Alexandria, Minnesota, United States
Site 102
Bloomington, Minnesota, United States
Site 106
Kansas City, Missouri, United States
Site 128
Bozeman, Montana, United States
Site 117
South Sioux City, Nebraska, United States
Site 114
South Orange, New Jersey, United States
Site 159
Albuquerque, New Mexico, United States
Site132
Poughkeepsie, New York, United States
Site 138
Goldsboro, North Carolina, United States
Site 156
Leland, North Carolina, United States
Site 107
West Fargo, North Dakota, United States
Site 103
Brecksville, Ohio, United States
Site 129
Cincinnati, Ohio, United States
Site 166
Moore, Oklahoma, United States
Site 152
Bend, Oregon, United States
Site 135
Medford, Oregon, United States
Site 150
Allenwood, Pennsylvania, United States
Site 140
Bala-Cynwyd, Pennsylvania, United States
Site 157
Kingston, Pennsylvania, United States
Site 145
Austin, Texas, United States
Site 158
Austin, Texas, United States
Site 113
Beaumont, Texas, United States
Site 110
Dallas, Texas, United States
Site 147
Houston, Texas, United States
Site 141
Houston, Texas, United States
Site 123
San Antonio, Texas, United States
Site 124
San Antonio, Texas, United States
Site 122
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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BL-SU01-ASRWE-4401
Identifier Type: -
Identifier Source: org_study_id
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