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

NCT ID: NCT06056154

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-17
• Study Completion Date: 2025-07-31

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

Patients undergoing routine clinical practice with ASQELIOTM monofocal LIO model QLIO130C.

Data will be extracted retrospectively from their medical records and prospectively in a single follow-up visit. All procedures performed are according to standard clinical practice.

LIO ASQELIO TM monofocal QLIO130C

Intervention Type: DEVICE

Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.

Interventions

LIO ASQELIO TM monofocal QLIO130C

Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with ASQELIO monofocal model QLIO130C.
• Subjects for whom postoperative emmetropia (±0.5 D spherical equivalent) was planned.

Exclusion Criteria

• Any pathology that reduces the potential Visual Acuity (VA) with its best correction beyond 0.30 logMAR.
• Previous corneal surgery.
• Rubella or surgery due to traumatic cataract.
• Ocular trauma or refractive surgery.
• Any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AST Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oftalmología Vistahermosa SL

Alicante, , Spain

Countries

Spain

Other Identifiers

ASQM012023

Identifier Type: -

Identifier Source: org_study_id