Visual Quality and Performance of Eyes With Asqelio™ EDoF Toric Lenses

NCT ID: NCT06707545

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2024-05-14

Brief Summary

This study evaluates the optical quality and clinical performance of the Asqelio™ EDOF Toric intraocular lens (IOL) in patients undergoing cataract surgery or refractive lensectomy. The Asqelio™ EDOF Toric IOL aims to provide improved vision at various distances and correct astigmatism compared to monofocal IOLs. Postoperative outcomes, including visual clarity, refractive correction, and patient satisfaction, will be assessed three months after surgery.

Detailed Description

Cataract surgery is one of the most common procedures worldwide, typically involving the replacement of the cloudy natural lens with an intraocular lens (IOL). Traditional monofocal IOLs correct vision for a single distance but do not address intermediate or near vision, leading to dependence on glasses. The Asqelio™ EDOF Toric IOL is designed to provide extended depth of focus, smoother transitions across distances, and astigmatism correction, potentially enhancing overall visual quality and reducing the need for glasses.

This study compares the optical performance and patient outcomes of the Asqelio™ EDOF Toric IOL with those of monofocal IOLs. Key measures include optical quality, visual acuity at multiple distances, refractive correction, and patient-reported satisfaction. Results will be collected during a three-month postoperative follow-up. The findings aim to inform the effectiveness of the Asqelio™ EDOF Toric IOL in improving visual outcomes and quality of life for patients.

Conditions

Cataract; Presbyopia Correction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Asqelio EDOF

Patients submitted to cataract surgery and implanted with the extended depth-of-focus intraocular lens Asqelio EDOF Toric

No interventions assigned to this group

Monofocal IOL

Patients submitted to cataract surgery and implanted with the TECNIS 1-Piece monofocal intraocular lens

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients aged 50 years or older who have undergone cataract surgery with phacoemulsification or refractive lensectomy, with bilateral implantation of the Asqelio EDOF toric IOL model ETLIO130C/ETPIO130C with a cylinder value of 0.0 D, or the spherical monofocal J&J TECNIS 1-Piece IOL model ZCB00.
• Patients who have signed the informed consent form.
• Clear intraocular media, except for the presence of cataracts in both eyes prior to surgery.
• Postoperative potential visual acuity of 20/25 or better

Exclusion Criteria

• Preoperative corneal astigmatism greater than 1.00D.
• Patients who do not provide informed consent.
• Patients who do not understand the study procedure.
• Previous corneal surgery or trauma.
• Irregular cornea (e.g., keratoconus).
• Choroidal hemorrhage.
• Microphthalmos.
• Severe corneal dystrophy.
• Uncontrolled or medically controlled glaucoma.
• Clinically significant macular changes.
• Severe concomitant ocular disease.
• Cataract unrelated to aging.
• Severe optic nerve atrophy.
• Diabetic retinopathy.
• Proliferative diabetic retinopathy.
• Amblyopia.
• Extremely shallow anterior chamber.
• Severe chronic uveitis.
• Pregnant or breastfeeding.
• Rubella.
• Mature/dense cataract preventing preoperative fundus examination.
• Previous retinal detachment.
• Concurrent participation in another drug or clinical device investigation.
• Expectation of needing another ocular surgery during the study period

• 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

Principal Investigators

Antonio Cano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital La Arruzafa

Locations

Hospital La Arruzafa

Córdoba, Cordoba, Spain

Countries

Spain

Other Identifiers

ASQE022022

Identifier Type: -

Identifier Source: org_study_id