CataractNCT05065749
Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens
An observational study of Cataract, run by AST Products, Inc. at 2 sites in Spain.
Trial summary
The study aims to evaluate the clinical outcomes six months after implantation of the trifocal diffractive intraocular lens Asqelio Trifocal IOL TFLIO130C in healthy subjects submitted to non-traumatic cataract surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 7 Mar 2022to Sep 2023
- 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 50 years of age or older submitted to cataract surgery and implanted with the Asqelio Trifocal IOL TFLIO130C according to regular clinical practice
Who may be able to join
- Patients submitted to cataract surgery and implanted with Asqelio Trifocal IOL TFLIO130C
- Patients signing a consent form
- Patients seeking spectacle-independence following surgery
- IOL power between +5.00 and +34.00 D
- Transparent intraocular media, except for the cataract prior to surgery, in both eyes
- Postoperatory potential visual acuity of 20/25 or better.
Who cannot join
- Preoperatory corneal astigmatism greater than 0.75D
- Patients not providing informed consent
- Previous corneal surgery or trauma
- Irregular cornea (i.e. keratoconus)
- Choroidal hemorrhage
- Microophthalmos
Show all 22Show fewer
- Severe corneal dystrophy
- Uncontrolled or medically controlled glaucoma
- Clinically significant macular changes
- Severe concomitant ocular disease
- Not age-related cataract
- Severe optic nerve atrophy
- Diabetic retinopathy
- Ambyopia
- Extremely shallow anterior chamber
- Severe chronic uveitis
- Pregnant or lactating
- Rubella
- Mature/Dense cataract sifficulting preoperative fundus assessment
- Previous retinal detachment
- Concurrent participation in other investigation using drugs or clinical devices
- Expecting ocular surgery within the study period
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
OftalVist Alicante
Alicante, 03015
OftalVist Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11408
About this study
The study aims to evaluate the clinical outcomes six months after implantation of the trifocal diffractive intraocular lens Asqelio Trifocal IOL TFLIO130C in healthy subjects submitted to non-traumatic cataract surgery.
This clinical performance will be assessed in terms of refractive error, visual performance at different distances, incidence of adverse events and complications following implantation, and patient satisfaction.
- Conditions
- Cataract
- Keywords
- cataract surgery, intraocular lens, multifocal refractive correction
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Percentage of subjects with adverse events (Ocular and Not Ocular, Severe and Not Severe), including secondary surgical procedures
Measured: Six months after implantation
Refraction
Manifest refraction both monocular and binocularly using subjective methods
Measured: Six months after implantation
Secondary outcomes (8)
Uncorrected visual acuity for distance (4m)
Monocular visual acuity for distance (4m), without any additional correction, using ETDRS vision chart
Measured: Six months after implantation
Best-corrected visual acuity for distance (4m)
Monocular visual acuity for distance (4m), with the best correction for distance, using ETDRS vision chart
Measured: Six months after implantation
Uncorrected visual acuity for intermediate
Monocular visual acuity for intermediate distance (60cm), without any additional correction, using ETDRS vision chart
Measured: Six months after implantation
Best-corrected visual acuity for intermediate
Monocular visual acuity for intermediate distance (60cm), with the best correction for distance, using ETDRS vision chart
Measured: Six months after implantation
Uncorrected visual acuity for near
Monocular visual acuity for near distance (40cm), without any additional correction, using ETDRS vision chart
Measured: Six months after implantation
Best-corrected visual acuity for near
Monocular visual acuity for near distance (40cm), with the best correction for distance, using ETDRS vision chart
Measured: Six months after implantation
Contrast sensitivity function (CSF)
CSF with best correction, with and without induced glare, using the Clinical Trial Suite
Measured: Six months after implantation
Defocus curve
Defocus curve of visual performance varying the stimulus vergence from -4.0 D to +1.0 D in 0.5 D steps with the best correction for distance
Measured: Six months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start7 Mar 2022
- Primary completionJun 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- NCT05065749
- Sponsor's protocol ID
- ASQT012021
- Status last verified
- Feb 2023
- First submitted
- 23 Sep 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tana-Rivero P, Tana-Sanz P, Tana-Sanz S, Montes-Mico R, Cervino A. Recognition vs resolution charts for defocus curve determination in trifocal intraocular lenses. J Cataract Refract Surg. 2024 Sep 1;50(9):942-946. doi: 10.1097/j.jcrs.0000000000001491.
PubMed 38780434
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens
- ClinicalTrials.gov ID
- NCT05065749
- Acronym / sponsor ID
- ASQT012021
- Conditions
- Cataract
- Keywords
- cataract surgery, intraocular lens, multifocal refractive correction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AST Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 4 Oct 2021 (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 study aims to evaluate the clinical outcomes six months after implantation of the trifocal diffractive intraocular lens Asqelio Trifocal IOL TFLIO130C in healthy subjects submitted to non-traumatic cataract surgery.
This clinical performance will be assessed in terms of refractive error, visual performance at different distances, incidence of adverse events and complications following implantation, and patient satisfaction.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 50 years of age or older submitted to cataract surgery and implanted with the Asqelio Trifocal IOL TFLIO130C according to regular clinical practice
Key inclusion criteria (6 listed)
- Patients submitted to cataract surgery and implanted with Asqelio Trifocal IOL TFLIO130C
- Patients signing a consent form
- Patients seeking spectacle-independence following surgery
- IOL power between +5.00 and +34.00 D
- Transparent intraocular media, except for the cataract prior to surgery, in both eyes
Key exclusion criteria (22 listed)
- Preoperatory corneal astigmatism greater than 0.75D
- Patients not providing informed consent
- Previous corneal surgery or trauma
- Irregular cornea (i.e. keratoconus)
- Choroidal hemorrhage
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
Adverse events
Time frame: Six months after implantation
Percentage of subjects with adverse events (Ocular and Not Ocular, Severe and Not Severe), including secondary surgical procedures
Refraction
Time frame: Six months after implantation
Manifest refraction both monocular and binocularly using subjective methods
8 secondary outcomes
Uncorrected visual acuity for distance (4m)
Time frame: Six months after implantation
Best-corrected visual acuity for distance (4m)
Time frame: Six months after implantation
Uncorrected visual acuity for intermediate
Time frame: Six months after implantation
Best-corrected visual acuity for intermediate
Time frame: Six months after implantation
Uncorrected visual acuity for near
Time frame: Six months after implantation
Best-corrected visual acuity for near
Time frame: Six months after implantation
Contrast sensitivity function (CSF)
Time frame: Six months after implantation
Defocus curve
Time frame: Six months after implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Derived from this study: PubMed 38780434Tana-Rivero P, Tana-Sanz P, Tana-Sanz S, Montes-Mico R, Cervino A. Recognition vs resolution charts for defocus curve determination in trifocal intraocular lenses. J Cataract Refract Surg. 2024 Sep 1;50(9):942-946. doi: 10.1097/j.jcrs.0000000000001491.
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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.
2 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 2 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 6 inclusion and 22 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Adverse events (time frame: Six months after 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?
On the ClinicalTrials.gov record for NCT05065749, which also lists 1 linked publication.
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 15 Feb 2023.