Visual Outcomes and Quality of Life After Vivity EDOF IOL Implantation in Early-Stage Keratoconus

The goal of this clinical trial is to learn if the Vivity Extended Depth of Focus intraocular lens works to improve vision in adults with cataracts and early-stage keratoconus. It will also learn about the safety and tolerance of this premium lens in patients with mild corneal irregularities. The main questions it aims to answer are: * Does the Vivity EDOF lens provide good distance vision (20/25 or better) in the dominant eye at 3 months after surgery? * Does it improve vision at intermediate and near distances compared to before surgery? * Does it preserve contrast sensitivity and optical quality despite mild corneal irregularities? * What is the patient-reported quality of life and satisfaction after implantation? * What visual disturbances (such as halos) do participants experience? All participants will: * Receive the Vivity EDOF intraocular lens (or its toric version if astigmatism is present) in both eyes during standard cataract surgery, with the second eye operated within 7 days; * Undergo comprehensive eye examinations before surgery including vision testing, corneal imaging, and optical quality measurements; * Attend a follow-up visit at 3 months after surgery for detailed vision testing at multiple distances, contrast sensitivity testing under different lighting conditions, halo assessment, and quality-of-life questionnaires.

NCT Number	NCT07338708
Lead Sponsor	Azienda Ospedaliera Universitaria Integrata Verona
Conditions	Cataract, Keratoconic Subjects
Enrollment	10 participants
Start Date	2024-09-17
Primary Completion	2025-05-13 (estimated)
Study Completion	2025-05-13 (estimated)
Updated on ClinicalTrials.gov	2026-01-15