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

In Situ Analysis of the Optical Quality and Visual Solvency of Eyes Implanted Bilaterally With the Asqelio™ EDoF Toric Extended-focus Intraocular Lens

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia Correction

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Spain
  • Cordoba
    • Córdoba, Cordoba, Spain, 14012
      • Hospital La Arruzafa

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All patients participating in the study will have been implanted with either the spherical monofocal intraocular lens (IOL) J&J TECNIS® 1-Piece model ZCB00 (Control Group), manufactured by Johnson & Johnson Vision (Jacksonville, USA), or the extended depth of focus (EDOF) toric IOL Asqelio™ model ETLIO130C/ETPIO130C (Study Group) from AST Products, Inc., Billerica, USA, with a cylinder value of 0.0 D. All patients will be treated according to standard clinical practice, meaning that both the preoperative evaluation and the surgical procedure for IOL implantation will have been completed prior to their inclusion in the study

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Asqelio EDOF; Patients submitted to cataract surgery and implanted with the extended depth-of-focus intraocular lens Asqelio EDOF Toric
Monofocal IOL; Patients submitted to cataract surgery and implanted with the TECNIS 1-Piece monofocal intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular dispersion index (OSI)	OSI value represents the ratio of the amount of light within an annular area of 12 to 20 arc minute and the light corresponding to a circular area of one minute of arc around the central peak. Determined using the OQAS II double pass system	Three months after intraocular lens implantation
Higher order aberrations Root Mean Square (HORMS)	The RMS value for higher order aberrations is calculated from the wavefront error map, determined using Hartmann-Shack wavefront aberrometry. Measured in microns	Three months after intraocular lens implantation
Ocular Spherical Aberration	Ocular spherical aberration was determined using Hartmann-Shack wavefront aberrometry. Measured in microns.	Three months after intraocular lens implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular visual acuity for distance vision with correction (CDVA)	The VA with its best correction placed under photopic conditions was determined monocularly at a distance of 4 meters. Measured in LogMAR units	Three months after intraocular lens implantation
Monocular visual acuity for distance vision without correction (UDVA)	The VA without correction under photopic conditions was determined monocularly at a distance of 4 meters. Measured in LogMAR units	Three months after intraocular lens implantation
Monocular visual acuity for intermediate vision with correction for distance (DCIVA)	The VA with its best correction placed under photopic conditions was determined monocularly at a distance of 67 centimeters. Measured in LogMAR units	Three months after intraocular lens implantation
Monocular visual acuity for intermediate vision without correction (UIVA)	The VA without correction under photopic conditions was determined monocularly at a distance of 67 centimeters. Measured in LogMAR units	Three months after intraocular lens implantation
Monocular visual acuity for near vision with correction for distance (DCNVA)	The VA with its best correction placed under photopic conditions was determined monocularly at a distance of 40 centimeters. Measured in LogMAR units	Three months after intraocular lens implantation
Monocular visual acuity for near vision without correction (UNVA)	The VA without correction under photopic conditions was determined monocularly at a distance of 40 centimeters. Measured in LogMAR units	Three months after intraocular lens implantation
Postoperative refractive error	Residual refractive error. Determined by manifest refraction. Measured in diopters	Three months after intraocular lens implantation
Monocular Contrast sensitivity	Determined using the best-corrected Pelli-Robson test. Determined in logCS units	Three months after intraocular lens implantation
Binocular Contrast sensitivity	Determined using the best-corrected Pelli-Robson test. Determined in logCS units	Three months after intraocular lens implantation
Defocus curve	Binocular defocus curve obtained for the EDOF IOL group by varying the vergence of the stimulus from -4.0 D to +2.0 D in steps of 0.5 D with the best correction for distance vision	Three months after intraocular lens implantation
CATQuest 9SF	Patient-reported outcomes on satisfaction and difficulty performing task after surgery. Obtained for the EDOF IOL group only. Each of the 9 items is scored using the Likert scale, from 1 for no difficulty/very satisfied, to 4 for very great difficulty/very dissatisfied, with higher scores indicating worse visual function.	Three months after surgery
Visual Symptoms questionnaire	Questionnaire exploring the frequency, intensity and bothersome of different visual symptoms. Obtained from the subjects in the EDOF IOL group only.The scoring of these responses ranges from 0 for Never/None to 3 for Very Often/Severe/A lot, with higher scores indicating worse quality of vision	Three months after surgery

Collaborators and Investigators

• Sponsor: AST Products, Inc.
• Investigators: Principal Investigator: Antonio Cano, MD, PhD, Hospital La Arruzafa

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): May 14, 2024
• Study Completion (Actual): May 14, 2024

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: intraocular lens; cataract surgery; optical quality; extended depth-of-focus
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ASQE022022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share individual participant data (IPD) for this study to ensure the confidentiality and privacy of our participants

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