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Lead
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
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study to Evaluate the enVista® Aspire (EA) Intraocular Lens in Subjects Undergoing Cataract Extraction
