CataractNCT06056154
Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design
An observational study of Cataract and Pseudophakia, run by AST Products, Inc. at 1 site in Spain.
Trial summary
The goal of this observational study is to learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract, Pseudophakia
- What is being tested?
- LIO ASQELIO TM monofocal QLIO130C
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jan 2024to Jul 2025
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects undergoing cataract surgery, implanted with ASQELIO monofocal model QLIO130C, and with a follow-up of more than 24 months.
Who may be able to join
- Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with ASQELIO monofocal model QLIO130C.
- Subjects for whom postoperative emmetropia (±0.5 D spherical equivalent) was planned.
Who cannot join
- Any pathology that reduces the potential Visual Acuity (VA) with its best correction beyond 0.30 logMAR.
- Previous corneal surgery.
- Rubella or surgery due to traumatic cataract.
- Ocular trauma or refractive surgery.
- Any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months.
Read the detailed description
This is a retro-prospective, post-marketing observational study of a CE-marked medical device. The efficacy and safety of the Asqelio monofocal intraocular lens (IOL) model QLIO130C from AST Products, Inc, Billerica, USA, will be studied in patients implanted according to standard clinical practice. Twelve-month follow-up data will be collected from the medical records of the patients included in the study, and after 24 months they will be scheduled for a review.
- Conditions
- Cataract, Pseudophakia
- Being tested
- LIO ASQELIO TM monofocal QLIO130C
- Medical subject headings
- Cataract, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIO ASQELIO TM monofocal QLIO130CDevice
Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing routine clinical practice with ASQELIOTM monofocal LIO model QLIO130C. | Data will be extracted retrospectively from their medical records and prospectively in a single follow-up visit. All procedures performed are according to standard clinical practice. Receives: Device: LIO ASQELIO TM monofocal QLIO130C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Posterior capsular opacity
Incidence of PCO
Measured: 24 months after IOL implantation
Intensity of Posterior capsular opacity
Intensity of PCO determined using LOCSIII Classification
Measured: 24 months after IOL implantation
Visual acuity
Best corrected distance visual acuity in LogMAR units using the ETDRS chart
Measured: At least 24 months after IOL implantation
Secondary outcomes (3)
Refraction
Residual refractive error in diopters determined objectively
Measured: At least 24 months after IOL implantation
Incidence of Glistening
Incidence of IOL glistening
Measured: At least 24 months after IOL implantation
Intensity of Glistening
Intensity of IOL glistening. It will be evaluated by examining the center of the IOL optical zone with the pupil dilated using a slit lamp. The intensity of glistening will be graded as the number of glistening in the central region according to the following scale: 0 = absent, 1 = traceable (countable vacuoles), 2=moderate (low density of countless vacuoles), and 3=severe (high density of countless vacuoles).
Measured: 24 months after IOL implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start17 Jan 2024
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (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
- Case only
- Time perspective
- Other
- Enrolment
- 150 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
- NCT06056154
- Sponsor's protocol ID
- ASQM012023
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design
- ClinicalTrials.gov ID
- NCT06056154
- Acronym / sponsor ID
- ASQM012023
- Conditions
- Cataract, Pseudophakia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AST Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 28 Sep 2023 (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 learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months.
Detailed description
This is a retro-prospective, post-marketing observational study of a CE-marked medical device. The efficacy and safety of the Asqelio monofocal intraocular lens (IOL) model QLIO130C from AST Products, Inc, Billerica, USA, will be studied in patients implanted according to standard clinical practice. Twelve-month follow-up data will be collected from the medical records of the patients included in the study, and after 24 months they will be scheduled for a review.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing routine clinical practice with ASQELIOTM monofocal LIO model QLIO130C. | – | Device: LIO ASQELIO TM monofocal QLIO130CData will be extracted retrospectively from their medical records and prospectively in a single follow-up visit. All procedures performed are according to standard clinical practice. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects undergoing cataract surgery, implanted with ASQELIO monofocal model QLIO130C, and with a follow-up of more than 24 months.
Key inclusion criteria (2 listed)
- Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with ASQELIO monofocal model QLIO130C.
- Subjects for whom postoperative emmetropia (±0.5 D spherical equivalent) was planned.
Key exclusion criteria (5 listed)
- Any pathology that reduces the potential Visual Acuity (VA) with its best correction beyond 0.30 logMAR.
- Previous corneal surgery.
- Rubella or surgery due to traumatic cataract.
- Ocular trauma or refractive surgery.
- Any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study
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 |
|---|---|---|
| LIO ASQELIO TM monofocal QLIO130CIntraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice. | Device | Patients undergoing routine clinical practice with ASQELIOTM monofocal LIO model QLIO130C. |
Primary outcome
Incidence of Posterior capsular opacity
Time frame: 24 months after IOL implantation
Incidence of PCO
Intensity of Posterior capsular opacity
Time frame: 24 months after IOL implantation
Intensity of PCO determined using LOCSIII Classification
Visual acuity
Time frame: At least 24 months after IOL implantation
Best corrected distance visual acuity in LogMAR units using the ETDRS chart
3 secondary outcomes
Refraction
Time frame: At least 24 months after IOL implantation
Incidence of Glistening
Time frame: At least 24 months after IOL implantation
Intensity of Glistening
Time frame: 24 months after IOL implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 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 and Pseudophakia, 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 2 inclusion and 5 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 8 Oct 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?
Incidence of Posterior capsular opacity (time frame: 24 months after IOL 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 8 Oct 2024.