CataractNCT06229756
Clinical Results of Asqelio™ EDOF Toric Soft Hydrophobic Intraocular Lens After Cataract Surgery
An observational study of Cataract, run by AST Products, Inc. at 1 site in Spain.
Trial summary
The goal of this observational study is to assess the clinical outcomes of binocular implantation of Asqelio EDOF Toric IOLs in healthy cataract patients. The main questions it aims to answer are: What is the visual performance at different distances 3 months after implantation of Asqelio EDOF Toric in both eyes? What… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 26 Oct 2022to Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects submitted to bilateral cataract surgery with implantation of extended depth of focus IOLs according to common clinical practice
Who may be able to join
- Patients 50 years old or more submitted to bilateral cataract surgery and implanted with Asqelio EDOF toric IOL, with cylinder value of 0.0 D.
- Patients signing informed consent
- Transparent media except for the cataracts
- Potential postoperatoria 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
- Microphtalmos
- Severe corneal dystrophy
- Uncontrolled or medically controlled glaucoma
- Clinically significant macular changes
- Concomitant severe eye disease
- Non-age-related cataract
- Severe optic nerve atrophy
- Diabetic retinopathy
- Proliferative diabetic retinopathy
- Amblyopia
- Extremely shallow anterior camera
- Severe chronic uveítis
- Pregnant or nursing
- Rubella
- Mature/dense cataract that makes it difficult to examine the fundus preoperatively.
- Previous retinal detachment
- Concurrent participation in other research with drugs or clinical devices
- Expect to require another eye surgery during the study period
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to assess the clinical outcomes of binocular implantation of Asqelio EDOF Toric IOLs in healthy cataract patients. The main questions it aims to answer are:
- What is the visual performance at different distances 3 months after implantation of Asqelio EDOF Toric in both eyes?
- What is the amount of residual refractive error following the implantation?
- What is the contrast sensitivity of patients 3 months after implantation of Asqelio EDOF Toric in both eyes?
- What is the optical quality of the eye implanted with Asqelio EDOF Toric IOL?
- What is the incidence and severity of visual symptoms after implantation of Asqelio EDOF Toric?
- What is the level of patient satisfaction after implantation of Asqelio EDOF Toric?
For this purpose, participants will be submitted to a comprehensive visual and refractive assessment, following common clinical practice, 3 months after binocular implantation of Asqelio EDOF Toric IOLs, and asked to complete visual symptoms and patient satisfaction questionnaires.
- Conditions
- Cataract
- 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 |
|---|---|---|
| EDOF Toric | Patient submitted to bilateral implantation of Asqelio EDOF Toric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Monocular Visual acuity for distance
Visual acuity without additional correction determined at a distance of 4 m in LogMAR units
Measured: 3 months after implantation
Uncorrected Monocular Visual acuity for intermediate distance
Visual acuity without additional correction determined at a distance of 67 cm in LogMAR units
Measured: 3 months after implantation
Uncorrected Monocular Visual acuity for near distance
Visual acuity without additional correction determined at a distance of 40 cm in LogMAR units
Measured: 3 months after implantation
Corrected Monocular Visual acuity for distance
Visual acuity with best correction determined at a distance of 4 m in LogMAR units
Measured: 3 months after implantation
Corrected Monocular Visual acuity for intermediate distance
Visual acuity with best correction determined at a distance of 67 cm in LogMAR units
Measured: 3 months after implantation
Corrected Monocular Visual acuity for near distance
Visual acuity with best correction determined at a distance of 40 cm in LogMAR units
Measured: 3 months after implantation
Refractive error
Residual refractive error after implantation obtained by subjective refraction methods
Measured: 3 months after implantation
Secondary outcomes (10)
Contrast sensitivity function under photopic conditions
Contrast sensitivity measured under photopic conditions for spatial frequencies of 3, 6, 12 and 18 cycles per degree using the Clinical Trial Suite in logCS units
Measured: 3 months after implantation
Contrast sensitivity function under mesopic conditions
Contrast sensitivity measured under mesopic conditions for spatial frequencies of 1.5, 3, 6 and 12 cycles per degree using the Clinical Trial Suite in logCS units
Measured: 3 months after implantation
Contrast sensitivity function under photopic conditions with glare
Contrast sensitivity measured under photopic conditions inducing glare, for spatial frequencies of 3, 6, 12 and 18 cycles per degree using the Clinical Trial Suite in logCS units
Measured: 3 months after implantation
Contrast sensitivity function under mesopic conditions with glare
Contrast sensitivity measured under mesopic conditions inducing glare, for spatial frequencies of 1.5, 3, 6 and 12 cycles per degree using the Clinical Trial Suite in logCS units
Measured: 3 months after implantation
Binocular defocus curve
Visual acuity in logMAR units under binocular conditions, determined varying the stimulus mergence using lenses from -4.00D to +2.00D in 0.50D steps and best refractive correction for distance
Measured: 3 months after implantation
Aberrometry
Optical quality measured as Zernike coefficients for total Root Mean Square of Higher order aberrations, and Spherical aberrations, expressed in microns
Measured: 3 months after implantation
Light distortion
Distortion of light as light distortion index, determined by means of the light distortion analyzer
Measured: 3 months after implantation
Patient-reported visual symptoms
Incidence and severity of visual symptoms, determined by means of a visual symptoms questionnaire. Incidence will be scored in a scale from 1 (never) to 4 (always), severity from 1 (none) to 4 (severe), and bothersome rom 1(none) to 4 (a lot)
Measured: 3 months after implantation
Patient-reported satisfaction
Level of satisfaction with vision and difficulty performing daily activities, determined by means of the CATQuest 9SF questionnaire, where items are scored in a scale from 1 (yes, a lot of difficulties) to 4 (no, no difficulties) and a "cannot decide" option. Satisfaction is scored from 1 (very unsatisfied) 4 (very satisfied) and a "cannot decide" option
Measured: 3 months after surgery
Incidence of Adverse events
Percentage of patients presenting adverse events (ocular and non ocular, severe and not severe), including secondary surgical procedures
Measured: 3 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 posted29 Jan 2024
- Study start26 Oct 2022
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AST Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229756
- Sponsor's protocol ID
- ASQE012022
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results of Asqelio™ EDOF Toric Soft Hydrophobic Intraocular Lens After Cataract Surgery
- ClinicalTrials.gov ID
- NCT06229756
- Acronym / sponsor ID
- ASQE012022
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AST Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 29 Jan 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.
The goal of this observational study is to assess the clinical outcomes of binocular implantation of Asqelio EDOF Toric IOLs in healthy cataract patients. The main questions it aims to answer are:
- What is the visual performance at different distances 3 months after implantation of Asqelio EDOF Toric in both eyes?
- What is the amount of residual refractive error following the implantation?
- What is the contrast sensitivity of patients 3 months after implantation of Asqelio EDOF Toric in both eyes?
- What is the optical quality of the eye implanted with Asqelio EDOF Toric IOL?
- What is the incidence and severity of visual symptoms after implantation of Asqelio EDOF Toric?
- What is the level of patient satisfaction after implantation of Asqelio EDOF Toric?
For this purpose, participants will be submitted to a comprehensive visual and refractive assessment, following common clinical practice, 3 months after binocular implantation of Asqelio EDOF Toric IOLs, and asked to complete visual symptoms and patient satisfaction questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EDOF Toric | – | –Patient submitted to bilateral implantation of Asqelio EDOF Toric IOL |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects submitted to bilateral cataract surgery with implantation of extended depth of focus IOLs according to common clinical practice
Key inclusion criteria (4 listed)
- Patients 50 years old or more submitted to bilateral cataract surgery and implanted with Asqelio EDOF toric IOL, with cylinder value of 0.0 D.
- Patients signing informed consent
- Transparent media except for the cataracts
- Potential postoperatoria 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
Uncorrected Monocular Visual acuity for distance
Time frame: 3 months after implantation
Visual acuity without additional correction determined at a distance of 4 m in LogMAR units
Uncorrected Monocular Visual acuity for intermediate distance
Time frame: 3 months after implantation
Visual acuity without additional correction determined at a distance of 67 cm in LogMAR units
Uncorrected Monocular Visual acuity for near distance
Time frame: 3 months after implantation
Visual acuity without additional correction determined at a distance of 40 cm in LogMAR units
Corrected Monocular Visual acuity for distance
Time frame: 3 months after implantation
Visual acuity with best correction determined at a distance of 4 m in LogMAR units
Corrected Monocular Visual acuity for intermediate distance
Time frame: 3 months after implantation
Visual acuity with best correction determined at a distance of 67 cm in LogMAR units
Corrected Monocular Visual acuity for near distance
Time frame: 3 months after implantation
Visual acuity with best correction determined at a distance of 40 cm in LogMAR units
Refractive error
Time frame: 3 months after implantation
Residual refractive error after implantation obtained by subjective refraction methods
10 secondary outcomes
Contrast sensitivity function under photopic conditions
Time frame: 3 months after implantation
Contrast sensitivity function under mesopic conditions
Time frame: 3 months after implantation
Contrast sensitivity function under photopic conditions with glare
Time frame: 3 months after implantation
Contrast sensitivity function under mesopic conditions with glare
Time frame: 3 months after implantation
Binocular defocus curve
Time frame: 3 months after implantation
Aberrometry
Time frame: 3 months after implantation
Light distortion
Time frame: 3 months after implantation
Patient-reported visual symptoms
Time frame: 3 months after implantation
Patient-reported satisfaction
Time frame: 3 months after surgery
Incidence of Adverse events
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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: status not confirmed, as of the sponsor's last update on 29 Jan 2024. 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?
Results are not available in the source record.
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?
Uncorrected Monocular Visual acuity for distance (time frame: 3 months after implantation). The study lists 7 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 29 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.