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Completed

NCT Number: NCT06333028

A 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

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SITE 104, Dover, New Jersey, United States

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About this study

A Non-interventional, Prospective, Multicenter, Single Arm, Post-Marketing Clinical Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

enVista Aspire EA IOLs

Device

Subjects bilaterally implanted with enVista Aspire EA IOLs

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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