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

Bausch + Lomb

Status: Completed

Conditions: Cataract

Treatments: Device: enVista Aspire EA IOLs

Study type: Observational

Funder types: Industry

Identifiers

NCT06333028

938

Details and patient eligibility

About

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

Full 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

Enrollment: 82 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

82 participants in 1 patient group

enVista Aspire intraocular lens (IOL)

Description:

Subjects bilaterally implanted with enVista Aspire EA IOLs.

Treatment:

Device: enVista Aspire EA IOLs