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

NCT06594185 | Completed FDA Device

• 1 other identifier: BL-SU01-ASRWE-4401
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 62

Brief 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

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs

EXPERIMENTAL

Device: enVista Aspire EA or Aspire Toric ETA IOLs

Interventions

enVista Aspire EA or Aspire Toric ETA IOLs DEVICE

enVista Aspire EA or Aspire Toric ETA IOLs

Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the Institutional Review Board (IRB)- approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.
• 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.
• 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.
• 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) in both eyes.
• Subjects with clinically significant preoperative corneal astigmatism must require an 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-up Clinical Investigation visits and procedures

You may not qualify if:

• 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.)
• 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, or a predisposition to, retinal detachment or proliferative diabetic retinopathy, in which 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 any disease producing an inflammatory reaction (e.g., iritis or uveitis)
• Aniridia
• Iris neovascularization
• 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).
• Microphthalmos or macrophthalmos
• Previous corneal transplant, prior YAG laser iridotomy, YAG vitreolysis, and prior phakic IOL insertions.
• 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.).
• Mechanical or surgical manipulation required to enlarge the pupil
• Vitreous loss (significant)

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (62)

Site 118

Birmingham, Alabama, 35209, United States

Location

Site 154

Bullhead City, Arizona, 86442, United States

Location

Site 137

Chandler, Arizona, 85224, United States

Location

Site 136

Mesa, Arizona, 85202, United States

Location

Site 162

Phoenix, Arizona, 85028, United States

Location

Site 105

Tucson, Arizona, 85704, United States

Location

Site 104

Bakersfield, California, 93309, United States

Location

Site 101

Beverly Hills, California, 90210, United States

Location

Site 151

Hemet, California, 92543, United States

Location

Site 111

Huntington Beach, California, 92647, United States

Location

Site 126

Long Beach, California, 90805, United States

Location

Site 149

Los Angeles, California, 90024, United States

Location

Site 155

Murrieta, California, 92562, United States

Location

Site 109

Newport Beach, California, 92707, United States

Location

Site 112

Orange, California, 92868, United States

Location

Site 144

Pasadena, California, 91107, United States

Location

Site 119

Torrance, California, 90505, United States

Location

Site 115

Upland, California, 91786, United States

Location

Site 161

Greenwich, Connecticut, 06830, United States

Location

Site 130

Milford, Connecticut, 06460, United States

Location

Site 164

Stamford, Connecticut, 06902, United States

Location

Site 125

Bradenton, Florida, 34209, United States

Location

Site 148

Mt. Dora, Florida, 32757, United States

Location

Site 143

Pompano Beach, Florida, 33064, United States

Location

Site 127

Tarpon Springs, Florida, 34689, United States

Location

Site 153

Winter Park, Florida, 32792, United States

Location

Site134

Gainesville, Georgia, 30501, United States

Location

Site 165

Roswell, Georgia, 30076, United States

Location

Site 163

Honolulu, Hawaii, 96813, United States

Location

Site 160

Honolulu, Hawaii, 96814, United States

Location

Site 108

Rock Island, Illinois, 61201, United States

Location

Site 133

Shreveport, Louisiana, 71103, United States

Location

Site 131

Birmingham, Michigan, 48009, United States

Location

Site 121

Alexandria, Minnesota, 56308, United States

Location

Site 142

Alexandria, Minnesota, 56308, United States

Location

Site 102

Bloomington, Minnesota, 55420, United States

Location

Site 106

Kansas City, Missouri, 64133, United States

Location

Site 128

Bozeman, Montana, 59718, United States

Location

Site 117

South Sioux City, Nebraska, 68776, United States

Location

Site 114

South Orange, New Jersey, 07079, United States

Location

Site 159

Albuquerque, New Mexico, 87109, United States

Location

Site132

Poughkeepsie, New York, 12603, United States

Location

Site 138

Goldsboro, North Carolina, 27534, United States

Location

Site 156

Leland, North Carolina, 28451, United States

Location

Site 107

West Fargo, North Dakota, 58078, United States

Location

Site 103

Brecksville, Ohio, 44142, United States

Location

Site 129

Cincinnati, Ohio, 45242, United States

Location

Site 166

Moore, Oklahoma, 73160, United States

Location

Site 152

Bend, Oregon, 97701, United States

Location

Site 135

Medford, Oregon, 97504, United States

Location

Site 150

Allenwood, Pennsylvania, 17810, United States

Location

Site 140

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Site 157

Kingston, Pennsylvania, 18704, United States

Location

Site 145

Austin, Texas, 78704, United States

Location

Site 158

Austin, Texas, 78731, United States

Location

Site 113

Beaumont, Texas, 77707, United States

Location

Site 110

Dallas, Texas, 75243, United States

Location

Site 147

Houston, Texas, 77008, United States

Location

Site 141

Houston, Texas, 77055, United States

Location

Site 123

San Antonio, Texas, 78209, United States

Location

Site 124

San Antonio, Texas, 78229, United States

Location

Site 122

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: August 29, 2024
• Primary Completion: May 21, 2025
• Study Completion: May 21, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (62)