At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessment of Tolerance and Visual Outcomes After Bilateral Implantation of a Premium Type Intraocular Lens (Acrysof IQ Vivity IOL) in Patients With Cataract and Mild Keratoconus
In Brief
A clinical study evaluating Extended Depth of Focus Intraocular Lens Implantation for Cataract and Keratoconic Subjects. Completed, enrolled 10 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Bilateral implantation of the AcrySof IQ Vivity (Alcon, Fort Worth, TX, USA) Extended Depth of Focus (EDOF) intraocular lens during phacoemulsification cataract surgery. The Vivity is a single-piece hydrophobic acrylic IOL (6.0 mm optic, 13.0 mm overall length) featuring non-diffractive X-WAVE wavefront-shaping technology with a slightly elevated central plateau (\~1 µm) and surrounding curvature modulation to extend focal range. It incorporates UV and blue light filtering with refractive index 1.55 at 35°C. The spherical model (powers +15.0 D to +25.0 D) or toric model (cylinder 1.03 D to 4.11 D at IOL plane) is selected based on corneal astigmatism. IOL power calculated using Kane formula targeting emmetropia. Surgery performed with 2.2 mm incision under topical anesthesia, with second-eye surgery within 7 days. This study specifically evaluates performance in patients with early-stage stable keratoconus.