CataractNCT04971863
In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens
An observational study of Cataract and Intraocular Lens Complication, run by AST Products, Inc. at 1 site in Spain.
Trial summary
This is a study to evaluate the 24 month postoperative incidence and intensity of posterior capsular opacity in patients submitted to cataract surgery and implanted with a hydrophobic monofocal IOL. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract, Intraocular Lens Complication
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 30 Mar 2022to 5 Jan 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 submitted to non-traumatic cataract surgery in at least 1 eye at the Hospital La Fé of Valencia, Spain
Who may be able to join
- Subjects 22 years or older submitted to cataract surgery in at least 1 eye and implanted with Asqelio monofocal or Clareon monofocal IOL
Who cannot join
- Any pathology reducing potential best-corrected visual acuity beyond 0.30 LogMAR, including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely shallow anterior chamber, microphthalmos, retinal detachment, severe recurrent anterior or posterior segment inflammation of unknown ethiology, iris neovascularization, uncontrolled glaucoma, clinically significant macular degeneration, or pseudoexfoliation diagnosis.
- Previous ocular surgery
- Rubella
- Surgery motivated by traumatic cataract
- Ocular trauma or refractive surgery
- Any other systemic or ocular condition that, in the investigator's opinion, should exclude the subject from study
- Requiring additional procedures due to intraoperatory complications, mechanical or surgical interventions for manipulating the pupil, excessive iris movility, significant vitreous loss, significant, anterior chamber hyphema, capsular annular breakage, or any other unrecognized ocular conditions that might compromise IOL positioning, as well as impossibility of locate the IOL in the capsular bag due to surgical complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens. Two-year Follow-up
This is a study to evaluate the 24 month postoperative incidence and intensity of posterior capsular opacity in patients submitted to cataract surgery and implanted with a hydrophobic monofocal IOL.
Read the detailed description
This study is a two-arm masked clinical evaluation study of incidence of PCO after successful bilateral cataract surgery with implantation of a monofocal IOL. Subjects will be assessed 24 months after IOL implantation. Clinical evaluations will include incidence of adverse events, patient satisfaction questionnaire, as well as measurements of visual performance, optical quality, presence and intensity of PCO, presence and intensity of IOL glistening.
- Conditions
- Cataract, Intraocular Lens Complication
- Keywords
- posterior capsule opacitication, incidence
- 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 |
|---|---|---|
| Clareon Monofocal IOL | Patients bilaterally implanted with the Clareon monofocal IOL | |
| Asqelio Monofocal IOL | Patients bilaterally implanted with the Asqelio monofocal IOL |
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 System
Measured: 24 months after IOL implantation
Secondary outcomes (5)
Visual acuity
Best corrected distance visual acuity in LogMAR units using the ETDRS chart
Measured: 1 month, 6 months, 12 months and 24 months after IOL implantation
Refraction
Residual refractive error in diopters determined objectively
Measured: 1 month, 6 months, 12 months and 24 months after IOL implantation
Optical quality
Higher-order wavefront aberrations determined using a clinical wavefront analyzer
Measured: 24 months after IOL implantation
Incidence of Glistening
Incidence of IOL glistening
Measured: 24 months after IOL implantation
Intensity of Glistening
Intensity of IOL glistening
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 posted22 Jul 2021
- Study start30 Mar 2022
- Primary completion31 Oct 2023
- Study completion5 Jan 2024
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-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- AST Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario La Fe
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971863
- Sponsor's protocol ID
- ASQM012021
- Status last verified
- Feb 2023
- First submitted
- 12 Jul 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hervas-Ontiveros A, Espana-Gregori E, Fresno-Canada C, Butron-Ruiz R, Cervino A. Posterior Capsular Opacification and Glistening in Hydrophobic Monofocal Biaspheric Intraocular Lens Two Years After Implantation: A Case Control Study. J Ophthalmol. 2024 Dec 31;2024:3520219. doi: 10.1155/joph/3520219. eCollection 2024.
PubMed 39781444
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
- In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens. Two-year Follow-up
- ClinicalTrials.gov ID
- NCT04971863
- Acronym / sponsor ID
- ASQM012021
- Conditions
- Cataract, Intraocular Lens Complication
- Keywords
- posterior capsule opacitication, incidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AST Products, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario La Fe
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 22 Jul 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.
This is a study to evaluate the 24 month postoperative incidence and intensity of posterior capsular opacity in patients submitted to cataract surgery and implanted with a hydrophobic monofocal IOL.
Detailed description
This study is a two-arm masked clinical evaluation study of incidence of PCO after successful bilateral cataract surgery with implantation of a monofocal IOL. Subjects will be assessed 24 months after IOL implantation. Clinical evaluations will include incidence of adverse events, patient satisfaction questionnaire, as well as measurements of visual performance, optical quality, presence and intensity of PCO, presence and intensity of IOL glistening.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clareon Monofocal IOL | – | –Patients bilaterally implanted with the Clareon monofocal IOL |
| Asqelio Monofocal IOL | – | –Patients bilaterally implanted with the Asqelio monofocal IOL |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects submitted to non-traumatic cataract surgery in at least 1 eye at the Hospital La Fé of Valencia, Spain
Key inclusion criteria (1 listed)
- Subjects 22 years or older submitted to cataract surgery in at least 1 eye and implanted with Asqelio monofocal or Clareon monofocal IOL
Key exclusion criteria (7 listed)
- Any pathology reducing potential best-corrected visual acuity beyond 0.30 LogMAR, including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely shallow anterior chamber, microphthalmos, retinal detachment, severe recurrent anterior or posterior segment inflammation of unknown ethiology, iris neovascularization, uncontrolled glaucoma, clinically significant macular degeneration, or pseudoexfoliation diagnosis.
- Previous ocular surgery
- Rubella
- Surgery motivated by traumatic cataract
- Ocular trauma or refractive surgery
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
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 System
5 secondary outcomes
Visual acuity
Time frame: 1 month, 6 months, 12 months and 24 months after IOL implantation
Refraction
Time frame: 1 month, 6 months, 12 months and 24 months after IOL implantation
Optical quality
Time frame: 24 months after IOL implantation
Incidence of Glistening
Time frame: 24 months after IOL implantation
Intensity of Glistening
Time frame: 24 months after IOL implantation
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 31 Jan 2024.
- Derived from this study: PubMed 39781444Hervas-Ontiveros A, Espana-Gregori E, Fresno-Canada C, Butron-Ruiz R, Cervino A. Posterior Capsular Opacification and Glistening in Hydrophobic Monofocal Biaspheric Intraocular Lens Two Years After Implantation: A Case Control Study. J Ophthalmol. 2024 Dec 31;2024:3520219. doi: 10.1155/joph/3520219. eCollection 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 Intraocular Lens Complication, 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 1 inclusion and 7 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 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 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?
Incidence of Posterior capsular opacity (time frame: 24 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?
On the ClinicalTrials.gov record for NCT04971863, 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 31 Jan 2024.