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

A Prospective, Multicenter, Open Label, Single Arm, Post-Marketing Clinical Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction

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

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: enVista Aspire EA or Aspire Toric ETA IOLs

• Study Type: Interventional
• Enrollment (Actual): 335
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Site 118
  • Arizona
    • Bullhead City, Arizona, United States, 86442
      • Site 154
    • Chandler, Arizona, United States, 85224
      • Site 137
    • Mesa, Arizona, United States, 85202
      • Site 136
    • Phoenix, Arizona, United States, 85028
      • Site 162
    • Tucson, Arizona, United States, 85704
      • Site 105
  • California
    • Bakersfield, California, United States, 93309
      • Site 104
    • Beverly Hills, California, United States, 90210
      • Site 101
    • Hemet, California, United States, 92543
      • Site 151
    • Huntington Beach, California, United States, 92647
      • Site 111
    • Long Beach, California, United States, 90805
      • Site 126
    • Los Angeles, California, United States, 90024
      • Site 149
    • Murrieta, California, United States, 92562
      • Site 155
    • Newport Beach, California, United States, 92707
      • Site 109
    • Orange, California, United States, 92868
      • Site 112
    • Pasadena, California, United States, 91107
      • Site 144
    • Torrance, California, United States, 90505
      • Site 119
    • Upland, California, United States, 91786
      • Site 115
  • Connecticut
    • Greenwich, Connecticut, United States, 06830
      • Site 161
    • Milford, Connecticut, United States, 06460
      • Site 130
    • Stamford, Connecticut, United States, 06902
      • Site 164
  • Florida
    • Bradenton, Florida, United States, 34209
      • Site 125
    • Mt. Dora, Florida, United States, 32757
      • Site 148
    • Pompano Beach, Florida, United States, 33064
      • Site 143
    • Tarpon Springs, Florida, United States, 34689
      • Site 127
    • Winter Park, Florida, United States, 32792
      • Site 153
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Site134
    • Roswell, Georgia, United States, 30076
      • Site 165
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Site 163
    • Honolulu, Hawaii, United States, 96814
      • Site 160
  • Illinois
    • Rock Island, Illinois, United States, 61201
      • Site 108
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Site 133
  • Michigan
    • Birmingham, Michigan, United States, 48009
      • Site 131
  • Minnesota
    • Alexandria, Minnesota, United States, 56308
      • Site 121
    • Alexandria, Minnesota, United States, 56308
      • Site 142
    • Bloomington, Minnesota, United States, 55420
      • Site 102
  • Missouri
    • Kansas City, Missouri, United States, 64133
      • Site 106
  • Montana
    • Bozeman, Montana, United States, 59718
      • Site 128
  • Nebraska
    • South Sioux City, Nebraska, United States, 68776
      • Site 117
  • New Jersey
    • South Orange, New Jersey, United States, 07079
      • Site 114
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Site 159
  • New York
    • Poughkeepsie, New York, United States, 12603
      • Site132
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534
      • Site 138
    • Leland, North Carolina, United States, 28451
      • Site 156
  • North Dakota
    • West Fargo, North Dakota, United States, 58078
      • Site 107
  • Ohio
    • Brecksville, Ohio, United States, 44142
      • Site 103
    • Cincinnati, Ohio, United States, 45242
      • Site 129
  • Oklahoma
    • Moore, Oklahoma, United States, 73160
      • Site 166
  • Oregon
    • Bend, Oregon, United States, 97701
      • Site 152
    • Medford, Oregon, United States, 97504
      • Site 135
  • Pennsylvania
    • Allenwood, Pennsylvania, United States, 17810
      • Site 150
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Site 140
    • Kingston, Pennsylvania, United States, 18704
      • Site 157
  • Texas
    • Austin, Texas, United States, 78704
      • Site 145
    • Austin, Texas, United States, 78731
      • Site 158
    • Beaumont, Texas, United States, 77707
      • Site 113
    • Dallas, Texas, United States, 75243
      • Site 110
    • Houston, Texas, United States, 77008
      • Site 147
    • Houston, Texas, United States, 77055
      • Site 141
    • San Antonio, Texas, United States, 78209
      • Site 123
    • San Antonio, Texas, United States, 78229
      • Site 124
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Site 122

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 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:

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 drug miosis, 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, 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs	Device: enVista Aspire EA or Aspire Toric ETA IOLs; enVista Aspire EA or Aspire Toric ETA IOLs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1	Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1	Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)
Percentage of subjects with binocular BCDVA of 20/40 or better at Postoperative Visit 1	Percentage of subjects with binocular BCDVA of 20/40 or better at Postoperative Visit 1	Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2024
• Primary Completion (Actual): May 21, 2025
• Study Completion (Actual): May 21, 2025

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: BL-SU01-ASRWE-4401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No