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Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens

NCT06935565 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-04-20

No results posted yet for this study

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

OTHER

Trifocal IOL implantation

Patients were implanted bilaterally with Asqelio Trifocal IOL 270±90 days before study visit

Sponsors & Collaborators

  • AST Products, Inc.

    lead INDUSTRY

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-02
Primary Completion
2023-06-15
Completion
2024-10-14

Countries

  • Spain

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 NCT06935565 on ClinicalTrials.gov