Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens

NCT06935565 | Completed

• 1 other identifier: ASQT012022
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

multifocal IOL; optical quality; visual performance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Visual acuity

  270±90 days after surgery

• Binocular defocus curve

  270±90 days after surgery

• Contrast sensitivity

  270±90 days after surgery

• Patient-Reported Outcomes - CATQuest9SF

  270±90 days after surgery

• Patient-Reported Outcomes - Visual symptoms

  270±90 days after surgery

Study Arms (1)

Trifocal

Patients implanted bilterally with Asqelio Trifocal IOL

Other: Trifocal IOL implantation

Interventions

Trifocal IOL implantation OTHER

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

Trifocal

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AST Products, Inc.: lead

Study Sites (1)

Clinica Baviera

Seville, Seville, 41013, Spain

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: April 20, 2025
• Study Start: September 2, 2022
• Primary Completion: June 15, 2023
• Study Completion: October 14, 2024
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

ES (1)