Assessment Of The Patient-Reported Outcomes Following Bilateral Implantation Of An Enhanced Monofocal Intraocular Lens In Cataract Patients

This study aimed to assess patient-reported outcomes following bilateral implantation of the enVista Aspire toric or non-toric intraocular lens (IOL) during cataract surgery.

57 sites in the United States

This prospective, multicenter, open-label, clinical study included subjects aged ≥ 22 years bilaterally implanted with enVista Aspire toric or non-toric IOLs following cataract surgery. The enVista Aspire IOL uses an optical modification of the posterior aspheric surface to create a small, continuous increase in IOL power within the central 1.5 mm diameter, slightly optimize the depth of focus for intermediate vision. All patients were targeted for plano to first minus. The patient-reported outcomes were evaluated using Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) scores and Near Activity Visual Questionnaire (NAVQ).

The AIOLIS scores showed that 90.0% to 96.8% of subjects ‘never’ or ‘sometimes’ experienced glare, halos, and starbursts, and 89.3% to 94.5% were ‘not at all’ or ‘a little bothered’. Overall, 92.5% of subjects reported that their vision was good to excellent, and 92.6% were seeing pretty to perfectly well without glasses. The analysis of NAVQ responses showed that 70-72% of patients could perform intermediate vision tasks without spectacles, such as viewing a computer or mobile device display, with ‘no or a little difficulty’. Nearly 67.9% of patients could read and write with no or little difficulty, and 60.4% could maintain focus during prolonged near work. Overall, 72% of patients were satisfied with their near vision.  

The enVista Aspire and Aspire Toric IOLs demonstrated good patient-reported outcomes as measured by validated questionnaires. Following bilateral implantation of the enhanced monofocal IOLs, more than 90% of patients experienced minimal to no visual symptoms and good to excellent vision. More than 92% of patients could see pretty well without glasses, and 72% were satisfied with their near vision.