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

NCT07338708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

  • Cataract
  • Keratoconic Subjects

Interventions

DEVICE

Extended Depth of Focus Intraocular Lens Implantation

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.

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2025-05-13
Completion
2025-05-13

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07338708 on ClinicalTrials.gov