Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens

NCT ID: NCT06935565

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-02
• Study Completion Date: 2024-10-14

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

Study Design

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

Study Groups

Trifocal

Patients implanted bilterally with Asqelio Trifocal IOL

Trifocal IOL implantation

Intervention Type: OTHER

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

Interventions

Trifocal IOL implantation

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AST Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinica Baviera

Seville, Seville, Spain

Countries

Spain

Other Identifiers

ASQT012022

Identifier Type: -

Identifier Source: org_study_id