CataractNCT06935565
Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens
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 evaluate whether the Asqelio™ Trifocal intraocular lens (IOL) can improve refractive outcomes and optical quality in patients (aged ≥45 years) undergoing cataract surgery or clear lens exchange, including both male and female participants. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Trifocal IOL implantation
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2022to 14 Oct 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: patients of usual clinical practice who have undergone conventional cataract surgery by phacoemulsification and wish to eliminate their refractive error and correct their presbyopia
Who may be able to join
- Patients 50 years of age or older undergoing cataract surgery by phacoemulsification and binocular IOL implant AsqelioTM Trifocal TFLIO130C
- Independence of use of glasses after surgery.
- IOL power between +5.0D and +34.0D
- Transparent intraocular media except for cataracts in both eyes.
- Potential postoperative visual acuity of 20/25 or better.
Who cannot join
- Preoperative corneal astigmatism greater than 1.0D
- Previous corneal surgery or trauma.
- Irregular cornea (e.g. keratoconus)
- Choroidal hemorrhage
- Microphtalmos
- Severe corneal dystrophy
Show all 21Show fewer
- 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 uveitis
- Pregnant or nursing
- Rubella
- Mature/dense cataract that makes it difficult to examine the eye fundus preoperatively.
- Previous retinal detachment
- Concurrent participation in other research with drugs or clinical devices
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to evaluate whether the Asqelio™ Trifocal intraocular lens (IOL) can improve refractive outcomes and optical quality in patients (aged ≥45 years) undergoing cataract surgery or clear lens exchange, including both male and female participants. The main questions it aims to answer are:
- Does the Asqelio™ Trifocal IOL provide accurate refractive correction with minimal residual refractive error?
- Does the lens reduce light distortion and provide good visual acuity at multiple distances (far, intermediate, near)?
Read more
Researchers will not use a comparison group, as this is a post-marketing, single-arm observational study.
Participants will undergo bilateral implantation of the Asqelio™ Trifocal IOL during cataract or lens replacement surgery and attend a study follow-up exam approximately 270±90 days post-surgery.
Complete evaluations including:
- Manifest refraction testing
- Uncorrected and corrected visual acuity at far, intermediate, and near distances
- Binocular defocus curve analysis
- Contrast sensitivity testing
- Light distortion analysis using a Light Distortion Analyzer
- Patient-reported outcomes via the Catquest-9SF and visual symptoms questionnaires.
- Conditions
- Cataract
- Being tested
- Trifocal IOL implantation
- Keywords
- multifocal IOL, optical quality, visual performance
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifocal IOL implantationOther
Patients were implanted bilaterally with Asqelio Trifocal IOL 270±90 days before study visit
| Study group | Role | What they receive |
|---|---|---|
| Trifocal | Patients implanted bilterally with Asqelio Trifocal IOL Receives: Other: Trifocal IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual refraction
Residual refractive error determined by subjective refraction procedures and expressed in diopters of spherical and cylindrical power
Measured: 270±90 days after surgery
Light Distortion Index
The distortion index is calculated as the ratio of the area of points missed by the subject and the total area explored using the Light Distortion Analyzer, and is expressed as a percentage
Measured: 270±90 days from surgery
Secondary outcomes (5)
Visual acuity
The VA with its best correction placed under photopic conditions was determined monocularly at a distance of 4 meters (UDVA and BCDVA), 60 cm (UIVA and BDCIVA), 40 cm (UNVA and BDCNVA), using the optotype of letters Early Treatment Diabetic Retinopathy Study (ETDRS)
Measured: 270±90 days after surgery
Binocular defocus curve
Binocular defocus curve was obtained by varying the stimulus vergence from -4.0 D to +2.0 D in 0.5 D steps with the best correction for distance vision
Measured: 270±90 days after surgery
Contrast sensitivity
The spatial profile of the stimulus was configured to diplay sinusoidal patterns in a circular window with sharp or smoothed edges. The patient's task was to describe the orientation of the stimulus, which changes at random among three options: vertical (grating at 0°), right (15°), or left (-15°), using the Topcon CC-100 instrument
Measured: 270±90 days after surgery
Patient-Reported Outcomes - CATQuest9SF
9-item questionnaire to determine patient activity limitations in daily life due to poor vision used due to its documented responsiveness in cataract surgery. It comprises 9 items with 4 response options, ranging from 4 for "very great difficulty/very dissatisfied" to 1 for "no difficulty/very satisfied", and a "cannot decide" additional option, which is treated as missing data. The questionnaire responses were scored using the Likert scale, from 1 for no difficulty/very satisfied, to 4 for very great difficulty/very dissatisfied.
Measured: 270±90 days after surgery
Patient-Reported Outcomes - Visual symptoms
A visual symptoms questionnaire explores the frequency, intensity and bothersome of 10 different and common visual symptoms. These symptoms are: Glare, Haloes, Starbursts, Foggy vision, Blurred vision, Distortion, Double vision, Fluctuation in vision, Difficulty focusing, and Difficulty judging distances or depth. A simulated image is shown to the patient to aid in the description of each of the symptoms, and they are asked to respond with 4 response options to the frequency of the symptoms, from 1 for "Never" to 4 "Very often", the intensity of the symptom, from 1 for "None" to 4 for "Severe", and the level of bothersome of the symptom, from 1 for "None" to 4 for "A lot". The scoring of these responses ranges from 0 for Never/None to 3 for Very Often/Severe/A lot
Measured: 270±90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start2 Sep 2022
- Primary completion15 Jun 2023
- Study completion14 Oct 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AST Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935565
- Sponsor's protocol ID
- ASQT012022
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the Asqelio™ Trifocal Diffractive Intraocular Lens
- ClinicalTrials.gov ID
- NCT06935565
- Acronym / sponsor ID
- ASQT012022
- Conditions
- Cataract
- Keywords
- multifocal IOL, optical quality, visual performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AST Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 20 Apr 2025 (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 evaluate whether the Asqelio™ Trifocal intraocular lens (IOL) can improve refractive outcomes and optical quality in patients (aged ≥45 years) undergoing cataract surgery or clear lens exchange, including both male and female participants. The main questions it aims to answer are:
- Does the Asqelio™ Trifocal IOL provide accurate refractive correction with minimal residual refractive error?
- Does the lens reduce light distortion and provide good visual acuity at multiple distances (far, intermediate, near)?
Researchers will not use a comparison group, as this is a post-marketing, single-arm observational study.
Participants will undergo bilateral implantation of the Asqelio™ Trifocal IOL during cataract or lens replacement surgery and attend a study follow-up exam approximately 270±90 days post-surgery.
Complete evaluations including:
- Manifest refraction testing
- Uncorrected and corrected visual acuity at far, intermediate, and near distances
- Binocular defocus curve analysis
- Contrast sensitivity testing
- Light distortion analysis using a Light Distortion Analyzer
- Patient-reported outcomes via the Catquest-9SF and visual symptoms questionnaires.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trifocal | – | Other: Trifocal IOL implantationPatients implanted bilterally with Asqelio Trifocal IOL |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients of usual clinical practice who have undergone conventional cataract surgery by phacoemulsification and wish to eliminate their refractive error and correct their presbyopia
Key inclusion criteria (5 listed)
- Patients 50 years of age or older undergoing cataract surgery by phacoemulsification and binocular IOL implant AsqelioTM Trifocal TFLIO130C
- Independence of use of glasses after surgery.
- IOL power between +5.0D and +34.0D
- Transparent intraocular media except for cataracts in both eyes.
- Potential postoperative visual acuity of 20/25 or better.
Key exclusion criteria (21 listed)
- Preoperative corneal astigmatism greater than 1.0D
- Previous corneal surgery or trauma.
- Irregular cornea (e.g. keratoconus)
- Choroidal hemorrhage
- Microphtalmos
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trifocal IOL implantationPatients were implanted bilaterally with Asqelio Trifocal IOL 270±90 days before study visit | Other | Trifocal |
Primary outcome
Residual refraction
Time frame: 270±90 days after surgery
Residual refractive error determined by subjective refraction procedures and expressed in diopters of spherical and cylindrical power
Light Distortion Index
Time frame: 270±90 days from surgery
The distortion index is calculated as the ratio of the area of points missed by the subject and the total area explored using the Light Distortion Analyzer, and is expressed as a percentage
5 secondary outcomes
Visual acuity
Time frame: 270±90 days after surgery
Binocular defocus curve
Time frame: 270±90 days after surgery
Contrast sensitivity
Time frame: 270±90 days after surgery
Patient-Reported Outcomes - CATQuest9SF
Time frame: 270±90 days after surgery
Patient-Reported Outcomes - Visual symptoms
Time frame: 270±90 days 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 20 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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 5 inclusion and 21 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 20 Apr 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?
Residual refraction (time frame: 270±90 days after surgery). The study lists 2 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 20 Apr 2025.