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

NCT06707545 | Completed

• 1 other identifier: ASQE022022
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Presbyopia Correction

Keywords

intraocular lens; extended depth-of-focus; cataract surgery; optical quality

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Monocular visual acuity for distance vision with correction (CDVA)

  Three months after intraocular lens implantation

• Monocular visual acuity for distance vision without correction (UDVA)

  Three months after intraocular lens implantation

• Monocular visual acuity for intermediate vision with correction for distance (DCIVA)

  Three months after intraocular lens implantation

• Monocular visual acuity for intermediate vision without correction (UIVA)

  Three months after intraocular lens implantation

• Monocular visual acuity for near vision with correction for distance (DCNVA)

  Three months after intraocular lens implantation

Study Arms (2)

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

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

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AST Products, Inc.: lead

Study Sites (1)

Hospital La Arruzafa

Córdoba, Cordoba, 14012, Spain

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Antonio Cano, MD, PhD

  Hospital La Arruzafa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: January 11, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: August 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)