A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction

Last updated: July 9, 2025
Sponsor: Bausch & Lomb Incorporated
Overall Status: Completed

Phase

N/A

Condition

Eye Disorders/infections

Vision Loss

Eye Disease

Treatment

enVista Aspire EA or Aspire Toric ETA IOLs

Clinical Study ID

NCT06594185
BL-SU01-ASRWE-4401
  • Ages > 22
  • All Genders

Study Summary

A study to evaluate the real-world clinical performance of the enVista Aspire and Aspire Toric intraocular lens (IOL) models EA and ETA and to assess surgeon and subject satisfaction

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 22 years of age or older on the date the Informed Consent Form (ICF) is signed.

  2. 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.

  3. 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.

  4. 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.

  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) inboth eyes.

  7. Subjects with clinically significant preoperative corneal astigmatism must requirean 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-upClinical Investigation visits and procedures

Exclusion

Exclusion Criteria:

  1. 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.)

  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, ora predisposition to, retinal detachment or proliferative diabetic retinopathy, inwhich 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 anydisease 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 isdefined as intraocular pressure (IOP) greater than 21 mm Hg in spite of maximallytolerated 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 priorphakic IOL insertions.

  13. 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.).

  14. Mechanical or surgical manipulation required to enlarge the pupil

  15. Vitreous loss (significant)

  16. Anterior chamber bleeding (significant)

Study Design

Total Participants: 335
Treatment Group(s): 1
Primary Treatment: enVista Aspire EA or Aspire Toric ETA IOLs
Phase:
Study Start date:
August 29, 2024
Estimated Completion Date:
May 21, 2025

Connect with a study center

  • Site 118

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Site 154

    Bullhead City, Arizona 86442
    United States

    Site Not Available

  • Site 137

    Chandler, Arizona 85224
    United States

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  • Site 136

    Mesa, Arizona 85202
    United States

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  • Site 162

    Phoenix, Arizona 85028
    United States

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  • Site 105

    Tucson, Arizona 85704
    United States

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  • Site 104

    Bakersfield, California 93309
    United States

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  • Site 101

    Beverly Hills, California 90210
    United States

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  • Site 151

    Hemet, California 92543
    United States

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  • Site 111

    Huntington Beach, California 92647
    United States

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  • Site 126

    Long Beach, California 90805
    United States

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  • Site 149

    Los Angeles, California 90024
    United States

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  • Site 155

    Murrieta, California 92562
    United States

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  • Site 109

    Newport Beach, California 92707
    United States

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  • Site 112

    Orange, California 92868
    United States

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  • Site 144

    Pasadena, California 91107
    United States

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  • Site 119

    Torrance, California 90505
    United States

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  • Site 115

    Upland, California 91786
    United States

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  • Site 161

    Greenwich, Connecticut 06830
    United States

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  • Site 130

    Milford, Connecticut 06460
    United States

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  • Site 164

    Stamford, Connecticut 06902
    United States

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  • Site 125

    Bradenton, Florida 34209
    United States

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  • Site 148

    Mount Dora, Florida 32757
    United States

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  • Site 143

    Pompano Beach, Florida 33064
    United States

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  • Site 127

    Tarpon Springs, Florida 34689
    United States

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  • Site 153

    Winter Park, Florida 32792
    United States

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  • Site134

    Gainesville, Georgia 30501
    United States

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  • Site 165

    Roswell, Georgia 30076
    United States

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  • Site 160

    Honolulu, Hawaii 96814
    United States

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  • Site 163

    Honolulu, Hawaii 96813
    United States

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  • Site 108

    Rock Island, Illinois 61201
    United States

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  • Site 133

    Shreveport, Louisiana 71103
    United States

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  • Site 116

    Bowie, Maryland 20716
    United States

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  • Site 131

    Birmingham, Michigan 48009
    United States

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  • Site 121

    Alexandria, Minnesota 56308
    United States

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  • Site 142

    Alexandria, Minnesota 56308
    United States

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  • Site 102

    Bloomington, Minnesota 55420
    United States

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  • Site 106

    Kansas City, Missouri 64133
    United States

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  • Site 128

    Bozeman, Montana 59718
    United States

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  • Site 117

    S. Sioux City, Nebraska 68776
    United States

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  • Site 114

    South Orange, New Jersey 07079
    United States

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  • Site 159

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Site 120

    New York, New York 10013
    United States

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  • Site132

    Poughkeepsie, New York 12603
    United States

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  • Site 138

    Goldsboro, North Carolina 27534
    United States

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  • Site 156

    Leland, North Carolina 28451
    United States

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  • Site 107

    W. Fargo, North Dakota 58078
    United States

    Site Not Available

  • Site 103

    Brecksville, Ohio 44142
    United States

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  • Site 129

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Site 166

    Moore, Oklahoma 73160
    United States

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  • Site 152

    Bend, Oregon 97701
    United States

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  • Site 135

    Medford, Oregon 97504
    United States

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  • Site 150

    Allenwood, Pennsylvania 17810
    United States

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  • Site 140

    Bala-Cynwyd, Pennsylvania 19004
    United States

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  • Site 157

    Kingston, Pennsylvania 18704
    United States

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  • Site 145

    Austin, Texas 78704
    United States

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  • Site 158

    Austin, Texas 78731
    United States

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  • Site 113

    Beaumont, Texas 77707
    United States

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  • Site 110

    Dallas, Texas 75243
    United States

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  • Site 141

    Houston, Texas 77055
    United States

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  • Site 147

    Houston, Texas 77008
    United States

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  • Site 123

    San Antonio, Texas 78209
    United States

    Site Not Available

  • Site 124

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Site 122

    Salt Lake City, Utah 84107
    United States

    Site Not Available

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