CataractNCT06333028
A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction
An observational study of Cataract, run by Bausch & Lomb Incorporated at 7 sites in United States.
Trial summary
A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction 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 IOLs
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 May 2024to 13 Mar 2025
- Phase
- Observational
- 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
Study population: Patient population at study site locations
Who may be able to join
- Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
- Subjects with a post operative BCDVA of 20/40 or better.
- Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB) approved ICF and authorization as appropriate for local privacy regulations and willing and able to comply with the follow-up study visit.
- Subjects implanted bilaterally with enVista Aspire EA IOLs, powers ranging from + 6 to + 34.0 D, prior to enrollment into the study on or after 1 November 2023.
- All subjects with a visually significant PCO (BCDVA worse than 20/40) who undergo a YAG capsulotomy may be enrolled 30 days post YAG procedure and with a postoperative BCDVA 20/40 or better.
Who cannot join
- Subjects with any serious ocular pathology or underlying systemic medical disease (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, could confound the results of the study.
- Subjects for whom a Toric IOL is indicated to achieve emmetropia.
- Subjects for whom monovision treatment is planned.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Site 106
Charleston, South Carolina, 29407
Site 107
Cranberry Township, Pennsylvania, 16066
SITE 104
Dover, New Jersey, 07801
Site 103
Garden City, New York, 11530
Site 102
Mount Pleasant, Wisconsin, 53405
Site 101
Sugar Land, Texas, 77478
Site 105
Woodland Park, New Jersey, 07424
About this study
Official title: A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction.
A Study to Evaluate the enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction
Read the detailed description
A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction
- Conditions
- Cataract
- Being tested
- enVista Aspire EA 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 IOLsDevice
Subjects bilaterally implanted with enVista Aspire EA IOLs
| Study group | Role | What they receive |
|---|---|---|
| enVista Aspire intraocular lens (IOL) | Subjects bilaterally implanted with enVista Aspire EA IOLs. Receives: Device: enVista Aspire EA IOLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean binocular BCDVA (logMAR) at Visit 1
Mean binocular best-corrected distance visual acuity (BCDVA) (logMAR) at Visit 1. Photopic BCDVA measured at 4 meters.
Measured: Day 60 to Day 270 after second eye implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start30 May 2024
- Primary completion13 Mar 2025
- Study completion13 Mar 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 82 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
- NCT06333028
- Sponsor's protocol ID
- 938
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2024
- Last updated
- 2 May 2025
- 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 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction.
- ClinicalTrials.gov ID
- NCT06333028
- Acronym / sponsor ID
- 938
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 27 Mar 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 enVista® Aspire (EA) intraocular lens in Subjects Undergoing Cataract Extraction
Detailed description
A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enVista Aspire intraocular lens (IOL) | – | Device: enVista Aspire EA IOLsSubjects bilaterally implanted with enVista Aspire EA IOLs. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population at study site locations
Key inclusion criteria (5 listed)
- Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
- Subjects with a post operative BCDVA of 20/40 or better.
- Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB) approved ICF and authorization as appropriate for local privacy regulations and willing and able to comply with the follow-up study visit.
- Subjects implanted bilaterally with enVista Aspire EA IOLs, powers ranging from + 6 to + 34.0 D, prior to enrollment into the study on or after 1 November 2023.
- All subjects with a visually significant PCO (BCDVA worse than 20/40) who undergo a YAG capsulotomy may be enrolled 30 days post YAG procedure and with a postoperative BCDVA 20/40 or better.
Key exclusion criteria (3 listed)
- Subjects with any serious ocular pathology or underlying systemic medical disease (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, could confound the results of the study.
- Subjects for whom a Toric IOL is indicated to achieve emmetropia.
- Subjects for whom monovision treatment is planned.
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 IOLsSubjects bilaterally implanted with enVista Aspire EA IOLs | Device | enVista Aspire intraocular lens (IOL) |
Primary outcome
Mean binocular BCDVA (logMAR) at Visit 1
Time frame: Day 60 to Day 270 after second eye implantation
Mean binocular best-corrected distance visual acuity (BCDVA) (logMAR) at Visit 1. Photopic BCDVA measured at 4 meters.
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 2 May 2025.
- 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Bausch & Lomb Incorporated at 7 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 5 inclusion and 3 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 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 BCDVA (logMAR) at Visit 1 (time frame: Day 60 to Day 270 after second eye implantation). 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 2 May 2025.