CataractNCT06101472
Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.
An observational study of Cataract, run by AST Products, Inc. at 3 sites in Spain.
Trial summary
The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens in candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- ASQELIO Toric Biaspheric Monofocal Lens
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 3 sitesSpain
- Study dates
- Feb 2024to 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects who are candidates for cataract surgery and implantation of toric monofocal ASQELIO IOL in at least one of their eyes.
Who may be able to join
- Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with LIO ASQELIO.
- Subjects for whom postoperative emmetropia was planned (±0.5 D spherical equivalent)
Who cannot join
- Preoperative corneal astigmatism less than 0.75D
- 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).
- Microphthalmos.
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- Severe corneal dystrophy.
- Pregnant or breastfeeding'.
- Rubella
- Mature/dense cataract making eye bottom preoperative examination difficult.
- 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
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Oftalvist Alicante
Alicante, 03013
José M Rubio, OD, +34965141500
Pedro Tañá Rivero, MD, PhD
- Recruiting
OftalVist Madrid
Madrid, 28006
Fátima Martínez Galdón, OD, +34915 42 60 10
Marta Ibarz Barbera, MD
- Recruiting
OftalVist Valencia
Valencia, 46004
Rafael Pastor Pascual, OD, +34963 513304
Francisco Pastor Pascual, MD, PhD
About this study
The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens in candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation.
Information will be obtained from patients operated by routine clinical practice with toric monofocal ASQELIO IOL in at least one eye. After confirmation of inclusion, the preoperative examination will be performed, and after surgery an evaluation will be performed the following day, one week, one month and three months after surgery.
Read the detailed description
In cataract surgery, the opacified lens is removed by phacoemulsification and replaced by an artificial IOL.The most common risk of cataract surgery is the development of a condition called posterior capsular opacification (PCO) that causes further deterioration of visual function. Toric intraocular lenses correct corneal astigmatism and avoid residual refractive errors in these subjects. For their efficacy in this refractive error correction, it is essential that, once implanted, these lenses are rotationally stable.The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens during the first 3 months after implantation.
All patients participating in the study are candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation model TLIO130 from AST Products, Inc., with CE marking.
- Conditions
- Cataract
- Being tested
- ASQELIO Toric Biaspheric Monofocal Lens
- Keywords
- Cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASQELIO Toric Biaspheric Monofocal LensDevice
Intraocular lens implantation in cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Pseudophakic subjects implanted with the ASQELIO toric IOL | Adult subjects undergoing cataract surgery by routine clinical practice with ASQELIO Toric Biaspheric Monofocal Lens in at least one eye. Receives: Device: ASQELIO Toric Biaspheric Monofocal Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotational stability of the implant
Evaluated at each visit by analysis of slit-lamp backlight images, following the method described by Wolffsohn and Buckhurst. By means of backlighting, the IOL markings indicating the axis in which the astigmatic power is located will be observed and by image analysis it will be determined and quantified whether the lens has been rotated.
Measured: During 3 months after IOL implantation
Visual acuity
Best corrected distance visual acuity in LogMAR units using the ETDRS chart
Measured: During 3 months after IOL implantation
Secondary outcomes (3)
Refraction
Using subjective refraction methods.
Measured: During 3 months after IOL implantation
Adverse events
Adverse events are obtained from solicited and spontaneous comments from the subjects and from observations made by the investigator.
Measured: During 3 months after IOL implantation
Satisfaction and quality of vision questionnaire
Collected from solicited and spontaneous comments from the subjects, as well as the Catquest-9SF questionnaire, validated in Spanish.
The subjective assessment of the quality of vision will be determined by an additional questionnaire about the presence of visual symptoms related to positive dysphotopsias (halos, glare and glare).
Measured: During 3 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 posted26 Oct 2023
- Study startFeb 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionOct 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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AST Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pedro Tañá, Dr, Principal investigator, Oftalmología Vistahermosa SL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101472
- Sponsor's protocol ID
- ASQM022023
- Status last verified
- Oct 2023
- First submitted
- 20 Sep 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.
- ClinicalTrials.gov ID
- NCT06101472
- Acronym / sponsor ID
- ASQM022023
- Conditions
- Cataract
- Keywords
- Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- AST Products, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Oct 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 evaluate the rotational stability and clinical performance of the ASQELIO Toric lens in candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation.
Information will be obtained from patients operated by routine clinical practice with toric monofocal ASQELIO IOL in at least one eye. After confirmation of inclusion, the preoperative examination will be performed, and after surgery an evaluation will be performed the following day, one week, one month and three months after surgery.
Detailed description
In cataract surgery, the opacified lens is removed by phacoemulsification and replaced by an artificial IOL.The most common risk of cataract surgery is the development of a condition called posterior capsular opacification (PCO) that causes further deterioration of visual function. Toric intraocular lenses correct corneal astigmatism and avoid residual refractive errors in these subjects. For their efficacy in this refractive error correction, it is essential that, once implanted, these lenses are rotationally stable.The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens during the first 3 months after implantation.
All patients participating in the study are candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation model TLIO130 from AST Products, Inc., with CE marking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pseudophakic subjects implanted with the ASQELIO toric IOL | – | Device: ASQELIO Toric Biaspheric Monofocal LensAdult subjects undergoing cataract surgery by routine clinical practice with ASQELIO Toric Biaspheric Monofocal Lens in at least one eye. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects who are candidates for cataract surgery and implantation of toric monofocal ASQELIO IOL in at least one of their eyes.
Key inclusion criteria (2 listed)
- Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with LIO ASQELIO.
- Subjects for whom postoperative emmetropia was planned (±0.5 D spherical equivalent)
Key exclusion criteria (13 listed)
- Preoperative corneal astigmatism less than 0.75D
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASQELIO Toric Biaspheric Monofocal LensIntraocular lens implantation in cataract surgery | Device | Pseudophakic subjects implanted with the ASQELIO toric IOL |
Primary outcome
Rotational stability of the implant
Time frame: During 3 months after IOL implantation
Evaluated at each visit by analysis of slit-lamp backlight images, following the method described by Wolffsohn and Buckhurst. By means of backlighting, the IOL markings indicating the axis in which the astigmatic power is located will be observed and by image analysis it will be determined and quantified whether the lens has been rotated.
Visual acuity
Time frame: During 3 months after IOL implantation
Best corrected distance visual acuity in LogMAR units using the ETDRS chart
3 secondary outcomes
Refraction
Time frame: During 3 months after IOL implantation
Adverse events
Time frame: During 3 months after IOL implantation
Satisfaction and quality of vision questionnaire
Time frame: During 3 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 31 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Pedro Tañá, Dr principal investigator
Oftalmología Vistahermosa SL
3 sites 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 3 sites 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 13 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 31 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 3 sites 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?
Contact Maria Cobo, Dr (+34963513304, maria.cobo@oftalvist.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotational stability of the implant (time frame: During 3 months after IOL implantation). 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 31 Jan 2024.