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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-30

Study Completion Date

2025-03-13

Brief Summary

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

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Detailed Description

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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

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Cataract

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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enVista Aspire intraocular lens (IOL)

Subjects bilaterally implanted with enVista Aspire EA IOLs.

enVista Aspire EA IOLs

Intervention Type DEVICE

Subjects bilaterally implanted with enVista Aspire EA IOLs

Interventions

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enVista Aspire EA IOLs

Subjects bilaterally implanted with enVista Aspire EA IOLs

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No