CataractNCT06707545
Visual Quality and Performance of Eyes With Asqelio™ EDoF Toric Lenses
An observational study of Cataract and Presbyopia Correction, run by AST Products, Inc. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract, Presbyopia Correction
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2023to 14 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- intraocular lens, extended depth-of-focus, cataract surgery, optical quality
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Three months after intraocular lens implantation
Ocular Spherical Aberration
Ocular spherical aberration was determined using Hartmann-Shack wavefront aberrometry. Measured in microns.
Measured: Three months after intraocular lens implantation
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Three months after intraocular lens implantation
Postoperative refractive error
Residual refractive error. Determined by manifest refraction. Measured in diopters
Measured: Three months after intraocular lens implantation
Monocular Contrast sensitivity
Determined using the best-corrected Pelli-Robson test. Determined in logCS units
Measured: Three months after intraocular lens implantation
Binocular Contrast sensitivity
Determined using the best-corrected Pelli-Robson test. Determined in logCS units
Measured: 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
Measured: 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.
Measured: 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
Measured: Three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start11 Jan 2023
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AST Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Cano, MD, PhD, Principal investigator, Hospital La Arruzafa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707545
- Sponsor's protocol ID
- ASQE022022
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data (IPD) for this study to ensure the confidentiality and privacy of our participants
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Situ Analysis of the Optical Quality and Visual Solvency of Eyes Implanted Bilaterally With the Asqelio™ EDoF Toric Extended-focus Intraocular Lens
- ClinicalTrials.gov ID
- NCT06707545
- Acronym / sponsor ID
- ASQE022022
- Conditions
- Cataract, Presbyopia Correction
- Keywords
- intraocular lens, extended depth-of-focus, cataract surgery, optical quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AST Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ocular dispersion index (OSI)
Time frame: Three months after intraocular lens implantation
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
Higher order aberrations Root Mean Square (HORMS)
Time frame: Three months after intraocular lens implantation
The RMS value for higher order aberrations is calculated from the wavefront error map, determined using Hartmann-Shack wavefront aberrometry. Measured in microns
Ocular Spherical Aberration
Time frame: Three months after intraocular lens implantation
Ocular spherical aberration was determined using Hartmann-Shack wavefront aberrometry. Measured in microns.
12 secondary outcomes
Monocular visual acuity for distance vision with correction (CDVA)
Time frame: Three months after intraocular lens implantation
Monocular visual acuity for distance vision without correction (UDVA)
Time frame: Three months after intraocular lens implantation
Monocular visual acuity for intermediate vision with correction for distance (DCIVA)
Time frame: Three months after intraocular lens implantation
Monocular visual acuity for intermediate vision without correction (UIVA)
Time frame: Three months after intraocular lens implantation
Monocular visual acuity for near vision with correction for distance (DCNVA)
Time frame: Three months after intraocular lens implantation
Monocular visual acuity for near vision without correction (UNVA)
Time frame: Three months after intraocular lens implantation
Postoperative refractive error
Time frame: Three months after intraocular lens implantation
Monocular Contrast sensitivity
Time frame: Three months after intraocular lens implantation
Binocular Contrast sensitivity
Time frame: Three months after intraocular lens implantation
Defocus curve
Time frame: Three months after intraocular lens implantation
CATQuest 9SF
Time frame: Three months after surgery
Visual Symptoms questionnaire
Time frame: Three months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data (IPD) for this study to ensure the confidentiality and privacy of our participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Cano, MD, PhD principal investigator
Hospital La Arruzafa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Presbyopia Correction, run by AST Products, Inc. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular dispersion index (OSI) (time frame: Three months after intraocular lens implantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.