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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cataract; Pseudophakia
• Intervention / Treatment: Device: LIO ASQELIO TM monofocal QLIO130C

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 46026
    • Oftalmología Vistahermosa SL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects undergoing cataract surgery, implanted with ASQELIO monofocal model QLIO130C, and with a follow-up of more than 24 months.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: LIO ASQELIO TM monofocal QLIO130C; Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Posterior capsular opacity	Incidence of PCO	24 months after IOL implantation
Intensity of Posterior capsular opacity	Intensity of PCO determined using LOCSIII Classification	24 months after IOL implantation
Visual acuity	Best corrected distance visual acuity in LogMAR units using the ETDRS chart	At least 24 months after IOL implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refraction	Residual refractive error in diopters determined objectively	At least 24 months after IOL implantation
Incidence of Glistening	Incidence of IOL glistening	At least 24 months after IOL implantation
Intensity of Glistening	Intensity of IOL glistening. It will be evaluated by examining the center of the IOL optical zone with the pupil dilated using a slit lamp. The intensity of glistening will be graded as the number of glistening in the central region according to the following scale: 0 = absent, 1 = traceable (countable vacuoles), 2=moderate (low density of countless vacuoles), and 3=severe (high density of countless vacuoles).	24 months after IOL implantation

Collaborators and Investigators

• Sponsor: AST Products, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 20, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Pseudophakia
• Other Study ID Numbers: ASQM012023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No