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

April 30, 2025 updated by: Bausch & Lomb Incorporated

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient population at study site locations

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
enVista Aspire intraocular lens (IOL)
Subjects bilaterally implanted with enVista Aspire EA IOLs.
Device: enVista Aspire EA IOLs
Subjects bilaterally implanted with enVista Aspire EA IOLs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 60 to Day 270 after second eye implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Actual)

March 13, 2025

Study Completion (Actual)

March 13, 2025

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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