Clinical trial NCT06594185: A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cataract
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 450
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1
timeFrame: Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)
measure: Percentage of subjects with binocular BCDVA of 20/40 or better at Postoperative Visit 1
timeFrame: Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site 118
state: Alabama
city: Bullhead City
country: United States
facility: Site 154
state: Arizona
city: Chandler
country: United States
facility: Site 137
state: Arizona
city: Mesa
country: United States
facility: Site 136
state: Arizona
city: Phoenix
country: United States
facility: Site 162
state: Arizona
city: Tucson
country: United States
facility: Site 105
state: Arizona
city: Bakersfield
country: United States
facility: Site 104
state: California
city: Beverly Hills
country: United States
facility: Site 101
state: California
city: Hemet
country: United States
facility: Site 151
state: California
city: Huntington Beach
country: United States
facility: Site 111
state: California
city: Long Beach
country: United States
facility: Site 126
state: California
city: Los Angeles
country: United States
facility: Site 149
state: California
city: Murrieta
country: United States
facility: Site 155
state: California
city: Newport Beach
country: United States
facility: Site 109
state: California
city: Orange
country: United States
facility: Site 112
state: California
city: Pasadena
country: United States
facility: Site 144
state: California
city: Torrance
country: United States
facility: Site 119
state: California
city: Upland
country: United States
facility: Site 115
state: California
city: Greenwich
country: United States
facility: Site 161
state: Connecticut
city: Milford
country: United States
facility: Site 130
state: Connecticut
city: Stamford
country: United States
facility: Site 164
state: Connecticut
city: Bradenton
country: United States
facility: Site 125
state: Florida
city: Mount Dora
country: United States
facility: Site 148
state: Florida
city: Pompano Beach
country: United States
facility: Site 143
state: Florida
city: Tarpon Springs
country: United States
facility: Site 127
state: Florida
city: Winter Park
country: United States
facility: Site 153
state: Florida
city: Gainesville
country: United States
facility: Site134
state: Georgia
city: Roswell
country: United States
facility: Site 165
state: Georgia
city: Honolulu
country: United States
facility: Site 163
state: Hawaii
city: Honolulu
country: United States
facility: Site 160
state: Hawaii
city: Rock Island
country: United States
facility: Site 108
state: Illinois
city: Shreveport
country: United States
facility: Site 133
state: Louisiana
city: Birmingham
country: United States
facility: Site 131
state: Michigan
city: Alexandria
country: United States
facility: Site 121
state: Minnesota
city: Alexandria
country: United States
facility: Site 142
state: Minnesota
city: Bloomington
country: United States
facility: Site 102
state: Minnesota
city: Kansas City
country: United States
facility: Site 106
state: Missouri
city: Bozeman
country: United States
facility: Site 128
state: Montana
city: S. Sioux City
country: United States
facility: Site 117
state: Nebraska
city: South Orange
country: United States
facility: Site 114
state: New Jersey
city: Albuquerque
country: United States
facility: Site 159
state: New Mexico
city: Poughkeepsie
country: United States
facility: Site132
state: New York
city: Goldsboro
country: United States
facility: Site 138
state: North Carolina
city: Leland
country: United States
facility: Site 156
state: North Carolina
city: W. Fargo
country: United States
facility: Site 107
state: North Dakota
city: Brecksville
country: United States
facility: Site 103
state: Ohio
city: Cincinnati
country: United States
facility: Site 129
state: Ohio
city: Moore
country: United States
facility: Site 166
state: Oklahoma
city: Bend
country: United States
facility: Site 152
state: Oregon
city: Medford
country: United States
facility: Site 135
state: Oregon
city: Allenwood
country: United States
facility: Site 150
state: Pennsylvania
city: Bala-Cynwyd
country: United States
facility: Site 140
state: Pennsylvania
city: Kingston
country: United States
facility: Site 157
state: Pennsylvania
city: Austin
country: United States
facility: Site 145
state: Texas
city: Austin
country: United States
facility: Site 158
state: Texas
city: Beaumont
country: United States
facility: Site 113
state: Texas
city: Dallas
country: United States
facility: Site 110
state: Texas
city: Houston
country: United States
facility: Site 147
state: Texas
city: Houston
country: United States
facility: Site 141
state: Texas
city: San Antonio
country: United States
facility: Site 123
state: Texas
city: San Antonio
country: United States
facility: Site 124
state: Texas
city: Salt Lake City
country: United States
facility: Site 122
state: Utah
Study officials:
References: