NCT06056154

Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: AST Products, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months.

Detailed description

This is a retro-prospective, post-marketing observational study of a CE-marked medical device. The efficacy and safety of the Asqelio monofocal intraocular lens (IOL) model QLIO130C from AST Products, Inc, Billerica, USA, will be studied in patients implanted according to standard clinical practice. Twelve-month follow-up data will be collected from the medical records of the patients included in the study, and after 24 months they will be scheduled for a review.

Conditions

• Cataract
• Pseudophakia

Interventions

Type	Name	Description
DEVICE	LIO ASQELIO TM monofocal QLIO130C	Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.

Timeline

• Start date: 2024-01-17
• Primary completion: 2025-05-01
• Completion: 2025-07-01
• First posted: 2023-09-28
• Last updated: 2024-10-08

Locations

1 site across 1 country: Spain