NCT06935565

Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: AST Products, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to evaluate whether the Asqelio™ Trifocal intraocular lens (IOL) can improve refractive outcomes and optical quality in patients (aged ≥45 years) undergoing cataract surgery or clear lens exchange, including both male and female participants. The main questions it aims to answer are: * Does the Asqelio™ Trifocal IOL provide accurate refractive correction with minimal residual refractive error? * Does the lens reduce light distortion and provide good visual acuity at multiple distances (far, intermediate, near)? Researchers will not use a comparison group, as this is a post-marketing, single-arm observational study. Participants will undergo bilateral implantation of the Asqelio™ Trifocal IOL during cataract or lens replacement surgery and attend a study follow-up exam approximately 270±90 days post-surgery. Complete evaluations including: * Manifest refraction testing * Uncorrected and corrected visual acuity at far, intermediate, and near distances * Binocular defocus curve analysis * Contrast sensitivity testing * Light distortion analysis using a Light Distortion Analyzer * Patient-reported outcomes via the Catquest-9SF and visual symptoms questionnaires.

Conditions

• Cataract

Interventions

Type	Name	Description
OTHER	Trifocal IOL implantation	Patients were implanted bilaterally with Asqelio Trifocal IOL 270±90 days before study visit

Timeline

• Start date: 2022-09-02
• Primary completion: 2023-06-15
• Completion: 2024-10-14
• First posted: 2025-04-20
• Last updated: 2025-04-20

Locations

1 site across 1 country: Spain