CataractNCT06594185
A Study to Evaluate Real World Outcomes of the enVista® Aspire (EA) and Aspire Toric (ETA) Intraocular Lens in Subjects Undergoing Cataract Extraction
A study testing enVista Aspire EA or Aspire Toric ETA IOLs in people with Cataract, run by Bausch & Lomb Incorporated at 62 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- enVista Aspire EA or Aspire Toric ETA IOLs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 62 sitesUnited States
- Study dates
- 29 Aug 2024to 21 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
Site 159
Albuquerque, New Mexico, 87109
Site 121
Alexandria, Minnesota, 56308
Site 142
Alexandria, Minnesota, 56308
Site 150
Allenwood, Pennsylvania, 17810
Site 145
Austin, Texas, 78704
Site 158
Austin, Texas, 78731
Site 104
Bakersfield, California, 93309
Site 140
Bala-Cynwyd, Pennsylvania, 19004
Site 113
Beaumont, Texas, 77707
Site 152
Bend, Oregon, 97701
Site 101
Beverly Hills, California, 90210
Site 118
Birmingham, Alabama, 35209
Site 131
Birmingham, Michigan, 48009
Site 102
Bloomington, Minnesota, 55420
Site 128
Bozeman, Montana, 59718
Site 125
Bradenton, Florida, 34209
Site 103
Brecksville, Ohio, 44142
Site 154
Bullhead City, Arizona, 86442
Site 137
Chandler, Arizona, 85224
Site 129
Cincinnati, Ohio, 45242
Site 110
Dallas, Texas, 75243
Site134
Gainesville, Georgia, 30501
Site 138
Goldsboro, North Carolina, 27534
Site 161
Greenwich, Connecticut, 06830
Site 151
Hemet, California, 92543
Site 163
Honolulu, Hawaii, 96813
Site 160
Honolulu, Hawaii, 96814
Site 147
Houston, Texas, 77008
Site 141
Houston, Texas, 77055
Site 111
Huntington Beach, California, 92647
Site 106
Kansas City, Missouri, 64133
Site 157
Kingston, Pennsylvania, 18704
Site 156
Leland, North Carolina, 28451
Site 126
Long Beach, California, 90805
Site 149
Los Angeles, California, 90024
Site 135
Medford, Oregon, 97504
Site 136
Mesa, Arizona, 85202
Site 130
Milford, Connecticut, 06460
Site 166
Moore, Oklahoma, 73160
Site 148
Mt. Dora, Florida, 32757
Site 155
Murrieta, California, 92562
Site 109
Newport Beach, California, 92707
Site 112
Orange, California, 92868
Site 144
Pasadena, California, 91107
Site 162
Phoenix, Arizona, 85028
Site 143
Pompano Beach, Florida, 33064
Site132
Poughkeepsie, New York, 12603
Site 108
Rock Island, Illinois, 61201
Site 165
Roswell, Georgia, 30076
Site 122
Salt Lake City, Utah, 84107
Site 123
San Antonio, Texas, 78209
Site 124
San Antonio, Texas, 78229
Site 133
Shreveport, Louisiana, 71103
Site 114
South Orange, New Jersey, 07079
Site 117
South Sioux City, Nebraska, 68776
Site 164
Stamford, Connecticut, 06902
Site 127
Tarpon Springs, Florida, 34689
Site 119
Torrance, California, 90505
Site 105
Tucson, Arizona, 85704
Site 115
Upland, California, 91786
Site 107
West Fargo, North Dakota, 58078
Site 153
Winter Park, Florida, 32792
About this study
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
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
- Being tested
- enVista Aspire EA or Aspire Toric ETA IOLs
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enVista Aspire EA or Aspire Toric ETA IOLsDevice
enVista Aspire EA or Aspire Toric ETA IOLs
| Study group | Role | What they receive |
|---|---|---|
| Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs | Experimental | Not described Receives: Device: enVista Aspire EA or Aspire Toric ETA IOLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1
Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1
Measured: 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
Measured: Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start29 Aug 2024
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594185
- Sponsor's protocol ID
- BL-SU01-ASRWE-4401
- Status last verified
- May 2026
- First submitted
- 10 Sep 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06594185
- Acronym / sponsor ID
- BL-SU01-ASRWE-4401
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs | Experimental | Device: enVista Aspire EA or Aspire Toric ETA IOLs |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enVista Aspire EA or Aspire Toric ETA IOLsenVista Aspire EA or Aspire Toric ETA IOLs | Device | Subjects bilaterally implanted with enVista Aspire EA or Aspire Toric ETA IOLs |
Primary outcome
Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enVista Aspire EA or Aspire Toric ETA IOLs in people with Cataract, run by Bausch & Lomb Incorporated at 62 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean binocular best-corrected distance visual acuity (BCDVA) at Postoperative Visit 1 (time frame: Assessed at Postop visit 1 (Day 14 to 42 days after second eye IOL implantation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.