A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction
- Conditions
- Cataract
- Interventions
- Device: enVista Aspire EA or Aspire Toric ETA IOLs
- Registration Number
- NCT06594185
- Lead Sponsor
- Bausch & Lomb Incorporated
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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 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
- 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)
- Anterior chamber bleeding (significant)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs enVista Aspire EA or Aspire Toric ETA IOLs -
- Primary Outcome Measures
Name Time Method 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) Mean binocular best-corrected distance visual acuity (BCDVA) 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) Percentage of subjects with binocular BCDVA of 20/40 or better at Postoperative Visit 1
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (62)
Site 161
🇺🇸Greenwich, Connecticut, United States
Site 130
🇺🇸Milford, Connecticut, United States
Site 127
🇺🇸Tarpon Springs, Florida, United States
Site 153
🇺🇸Winter Park, Florida, United States
Site 124
🇺🇸San Antonio, Texas, United States
Site 122
🇺🇸Salt Lake City, Utah, United States
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 164
🇺🇸Stamford, Connecticut, United States
Site 125
🇺🇸Bradenton, Florida, United States
Site 148
🇺🇸Mount Dora, Florida, United States
Site 143
🇺🇸Pompano Beach, 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
🇺🇸S. 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
🇺🇸W. Fargo, North Dakota, United States
Site 110
🇺🇸Dallas, Texas, United States
Site 147
🇺🇸Houston, Texas, United States
Site 141
🇺🇸Houston, Texas, United States
Site 103
🇺🇸Brecksville, Ohio, United States
Site 123
🇺🇸San Antonio, Texas, 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