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CompletedNCT06333028Updated May 2, 2025

A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction

An observational study in Cataract, sponsored by Bausch & Lomb Incorporated. Completed at 7 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Bausch & Lomb Incorporated · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
82
Ages
22 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Cataract

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 82 is close to the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient population at study site locations

Inclusion criteria

  1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
  2. Subjects with a post operative BCDVA of 20/40 or better.
  3. 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.
  4. 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.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Subjects for whom a Toric IOL is indicated to achieve emmetropia.
  3. Subjects for whom monovision treatment is planned.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
82 participants (actual)
Patient registry
No

Groups and cohorts

  • enVista Aspire intraocular lens (IOL)

    Subjects bilaterally implanted with enVista Aspire EA IOLs.

    Device: enVista Aspire EA IOLs

Interventions

  • DeviceenVista Aspire EA IOLs

    Subjects bilaterally implanted with enVista Aspire EA IOLs

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 60 to Day 270 after second eye implantation

07

Study locations

7 sites
  • SITE 104
    Dover, New Jersey 07801, United States
  • Site 105
    Woodland Park, New Jersey 07424, United States
  • Site 103
    Garden City, New York 11530, United States
  • Site 107
    Cranberry Township, Pennsylvania 16066, United States
  • Site 106
    Charleston, South Carolina 29407, United States
  • Site 101
    Sugar Land, Texas 77478, United States
  • Site 102
    Mount Pleasant, Wisconsin 53405, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06333028
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
Mar 27, 2024
Start date
May 30, 2024
Primary completion
Mar 13, 2025
Completion
Mar 13, 2025
Last update
May 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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