An observational study in Cataract and Presbyopia Correction, sponsored by AST Products, Inc.. Completed at 1 site in Spain. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by AST Products, Inc. · Observational
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.
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 40 is below the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →AST Products, Inc. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients submitted to cataract surgery and implanted with the extended depth-of-focus intraocular lens Asqelio EDOF Toric
Patients submitted to cataract surgery and implanted with the TECNIS 1-Piece monofocal intraocular lens
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
Time frame: 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
Time frame: Three months after intraocular lens implantation
Ocular Spherical Aberration
Ocular spherical aberration was determined using Hartmann-Shack wavefront aberrometry. Measured in microns.
Time frame: Three months after intraocular lens implantation
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Three months after intraocular lens implantation
Postoperative refractive error
Residual refractive error. Determined by manifest refraction. Measured in diopters
Time frame: Three months after intraocular lens implantation
Monocular Contrast sensitivity
Determined using the best-corrected Pelli-Robson test. Determined in logCS units
Time frame: Three months after intraocular lens implantation
Binocular Contrast sensitivity
Determined using the best-corrected Pelli-Robson test. Determined in logCS units
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Three months after surgery
Plan to share: No — We do not plan to share individual participant data (IPD) for this study to ensure the confidentiality and privacy of our participants
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in May 2024, 16 months.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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AST Products, Inc.