Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Other: Trifocal IOL implantation

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41013
    • Clinica Baviera

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

patients of usual clinical practice who have undergone conventional cataract surgery by phacoemulsification and wish to eliminate their refractive error and correct their presbyopia

Description

Inclusion Criteria:

• Patients 50 years of age or older undergoing cataract surgery by phacoemulsification and binocular IOL implant AsqelioTM Trifocal TFLIO130C
• Independence of use of glasses after surgery.
• IOL power between +5.0D and +34.0D
• Transparent intraocular media except for cataracts in both eyes.
• Potential postoperative visual acuity of 20/25 or better.

Exclusion Criteria:

• Preoperative corneal astigmatism greater than 1.0D
• Previous corneal surgery or trauma.
• Irregular cornea (e.g. keratoconus)
• Choroidal hemorrhage
• Microphtalmos
• Severe corneal dystrophy
• Uncontrolled or medically controlled glaucoma
• Clinically significant macular changes
• Concomitant severe eye disease
• Non-age-related cataract
• Severe optic nerve atrophy
• Diabetic retinopathy
• Proliferative diabetic retinopathy
• Amblyopia
• Extremely shallow anterior camera
• Severe chronic uveitis
• Pregnant or nursing
• Rubella
• Mature/dense cataract that makes it difficult to examine the eye fundus preoperatively.
• Previous retinal detachment
• Concurrent participation in other research with drugs or clinical devices

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trifocal; Patients implanted bilterally with Asqelio Trifocal IOL	Other: Trifocal IOL implantation; Patients were implanted bilaterally with Asqelio Trifocal IOL 270±90 days before study visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual refraction	Residual refractive error determined by subjective refraction procedures and expressed in diopters of spherical and cylindrical power	270±90 days after surgery
Light Distortion Index	The distortion index is calculated as the ratio of the area of points missed by the subject and the total area explored using the Light Distortion Analyzer, and is expressed as a percentage	270±90 days from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	The VA with its best correction placed under photopic conditions was determined monocularly at a distance of 4 meters (UDVA and BCDVA), 60 cm (UIVA and BDCIVA), 40 cm (UNVA and BDCNVA), using the optotype of letters Early Treatment Diabetic Retinopathy Study (ETDRS)	270±90 days after surgery
Binocular defocus curve	Binocular defocus curve was obtained by varying the stimulus vergence from -4.0 D to +2.0 D in 0.5 D steps with the best correction for distance vision	270±90 days after surgery
Contrast sensitivity	The spatial profile of the stimulus was configured to diplay sinusoidal patterns in a circular window with sharp or smoothed edges. The patient's task was to describe the orientation of the stimulus, which changes at random among three options: vertical (grating at 0°), right (15°), or left (-15°), using the Topcon CC-100 instrument	270±90 days after surgery
Patient-Reported Outcomes - CATQuest9SF	9-item questionnaire to determine patient activity limitations in daily life due to poor vision used due to its documented responsiveness in cataract surgery. It comprises 9 items with 4 response options, ranging from 4 for "very great difficulty/very dissatisfied" to 1 for "no difficulty/very satisfied", and a "cannot decide" additional option, which is treated as missing data. The questionnaire responses were scored using the Likert scale, from 1 for no difficulty/very satisfied, to 4 for very great difficulty/very dissatisfied.	270±90 days after surgery
Patient-Reported Outcomes - Visual symptoms	A visual symptoms questionnaire explores the frequency, intensity and bothersome of 10 different and common visual symptoms. These symptoms are: Glare, Haloes, Starbursts, Foggy vision, Blurred vision, Distortion, Double vision, Fluctuation in vision, Difficulty focusing, and Difficulty judging distances or depth. A simulated image is shown to the patient to aid in the description of each of the symptoms, and they are asked to respond with 4 response options to the frequency of the symptoms, from 1 for "Never" to 4 "Very often", the intensity of the symptom, from 1 for "None" to 4 for "Severe", and the level of bothersome of the symptom, from 1 for "None" to 4 for "A lot". The scoring of these responses ranges from 0 for Never/None to 3 for Very Often/Severe/A lot	270±90 days after surgery

Collaborators and Investigators

• Sponsor: AST Products, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): October 14, 2024

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: multifocal IOL; visual performance; optical quality
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ASQT012022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No