CataractNCT07140029
Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus
An observational study of Cataract and Lens Implantation, Intraocular, run by AST Products, Inc. at 1 site in Spain.
Trial summary
The goal of this observational study is to evaluate whether different intraocular lens (IOL) injectors affect surgical outcomes in patients aged 40 and older undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract, Lens Implantation, Intraocular
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (aged 40 and older) scheduled for routine cataract surgery using phacoemulsification and implantation of an Asqelio™ monofocal intraocular lens. Participants must have clear intraocular media except for the presence of cataract and meet standard clinical criteria for lens implantation. Patients are recruited from a single ophthalmology center in Spain and are typical candidates for conventional cataract surgery.
Who may be able to join
- Age 40 years or older
- Scheduled for cataract surgery using phacoemulsification technique
- Planned implantation of an Asqelio™ monofocal intraocular lens (IOL)
- Clear intraocular media, except for the presence of cataract (i.e., no other significant ocular opacities)
Who cannot join
- Preoperative corneal astigmatism > 1.0 diopter (D)
- Previous corneal surgery or history of ocular trauma
- Irregular cornea (e.g., keratoconus)
- Choroidal hemorrhage
- Microphthalmos
- Severe corneal dystrophy
Show all 21Show fewer
- Uncontrolled or medically controlled glaucoma
- Clinically significant macular changes
- Severe concomitant ocular disease
- Cataract not related to aging
- Severe optic nerve atrophy
- Diabetic retinopathy
- Proliferative diabetic retinopathy
- Amblyopia
- Extremely shallow anterior chamber
- Severe chronic uveitis
- Pregnant or breastfeeding
- Rubella
- Mature or dense cataracts that prevent preoperative retinal examination
- History of retinal detachment
- Concurrent participation in another drug or medical device clinical study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Clínica OftalVist Sevilla
Seville, Sevilla, 41018
Adrian Hernandez Martinez, MD, PhD, +34 954 933 930, oft.ahm@gmail.com
About this study
The goal of this observational study is to evaluate whether different intraocular lens (IOL) injectors affect surgical outcomes in patients aged 40 and older undergoing cataract surgery. The main questions it aims to answer are:
- Do different IOL injectors change the size of the corneal incision during surgery?
- Do the injectors lead to different rates of complications during or after surgery? Researchers will compare the use of three different IOL injectors: two preloaded models (pioli™ and pioli™ Plus) and one manually loaded model (lioli™), to see if the preloaded systems improve surgical results compared to the manual one.
Read more
Participants will:
- Undergo routine cataract surgery using one of the three injectors, randomly assigned.
- Have measurements taken before and after surgery (e.g., vision tests, corneal incision size).
- Be monitored for any side effects or complications during and after the procedure.
- Conditions
- Cataract, Lens Implantation, Intraocular
- 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 |
|---|---|---|
| pioli™ rD | Participants receiving the pioli™ preloaded injector with the rD model, used for IOL powers < 25.5 diopters | |
| pioli™ Plus rD | Participants receiving the pioli™ Plus preloaded injector with the rD model, used for IOL powers < 25.5 diopters | |
| lioli™ <25.5D | Participants receiving the lioli™ manually loaded injector for IOL powers < 25.5 diopters | |
| pioli™ rC | Participants receiving the pioli™ preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters | |
| pioli™ Plus rC | Participants receiving the pioli™ Plus preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters | |
| lioli™ ≥25.5D | Participants receiving the lioli™ manually loaded injector for IOL powers ≥ 25.5 diopters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Corneal Incision Size
Measurement of the corneal incision before and after intraocular lens (IOL) insertion using each type of injector. Difference in incision size (in mm)
Measured: Day of surgery (intraoperative)
Incidence of Adverse Events
Number and type of ocular and non-ocular adverse events (serious and non-serious) recorded from initiation of the intra-ocular lens (IOL) implantation, both intraoperative and early postoperative period (up to 30 days). Percentage of participants with any AE
Measured: From surgical incision to end of surgery, assessed up to 120 minutes (intraoperative), and From end of surgery until postoperative day 30 (postoperative)
Secondary outcomes (1)
Procedure Duration
Time required to insert the IOL using each type of injector. Time in seconds (measured with a stopwatch)
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionDec 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AST Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrián Hernández Martínez, MD, PhD, Principal investigator, OftalVist Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140029
- Sponsor's protocol ID
- PIOLI012022
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study does not include a plan to share individual participant data (IPD), as data will be anonymized and used solely for internal analysis and regulatory reporting
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus
- ClinicalTrials.gov ID
- NCT07140029
- Acronym / sponsor ID
- PIOLI012022
- Conditions
- Cataract, Lens Implantation, Intraocular
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AST Products, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Aug 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 different intraocular lens (IOL) injectors affect surgical outcomes in patients aged 40 and older undergoing cataract surgery. The main questions it aims to answer are:
- Do different IOL injectors change the size of the corneal incision during surgery?
- Do the injectors lead to different rates of complications during or after surgery? Researchers will compare the use of three different IOL injectors: two preloaded models (pioli™ and pioli™ Plus) and one manually loaded model (lioli™), to see if the preloaded systems improve surgical results compared to the manual one.
Participants will:
- Undergo routine cataract surgery using one of the three injectors, randomly assigned.
- Have measurements taken before and after surgery (e.g., vision tests, corneal incision size).
- Be monitored for any side effects or complications during and after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| pioli™ rD | – | –Participants receiving the pioli™ preloaded injector with the rD model, used for IOL powers < 25.5 diopters |
| pioli™ Plus rD | – | –Participants receiving the pioli™ Plus preloaded injector with the rD model, used for IOL powers < 25.5 diopters |
| lioli™ <25.5D | – | –Participants receiving the lioli™ manually loaded injector for IOL powers < 25.5 diopters |
| pioli™ rC | – | –Participants receiving the pioli™ preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters |
| pioli™ Plus rC | – | –Participants receiving the pioli™ Plus preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters |
| lioli™ ≥25.5D | – | –Participants receiving the lioli™ manually loaded injector for IOL powers ≥ 25.5 diopters |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (aged 40 and older) scheduled for routine cataract surgery using phacoemulsification and implantation of an Asqelio™ monofocal intraocular lens. Participants must have clear intraocular media except for the presence of cataract and meet standard clinical criteria for lens implantation. Patients are recruited from a single ophthalmology center in Spain and are typical candidates for conventional cataract surgery.
Key inclusion criteria (4 listed)
- Age 40 years or older
- Scheduled for cataract surgery using phacoemulsification technique
- Planned implantation of an Asqelio™ monofocal intraocular lens (IOL)
- Clear intraocular media, except for the presence of cataract (i.e., no other significant ocular opacities)
Key exclusion criteria (21 listed)
- Preoperative corneal astigmatism > 1.0 diopter (D)
- Previous corneal surgery or history of ocular trauma
- Irregular cornea (e.g., keratoconus)
- Choroidal hemorrhage
- Microphthalmos
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
Change in Corneal Incision Size
Time frame: Day of surgery (intraoperative)
Measurement of the corneal incision before and after intraocular lens (IOL) insertion using each type of injector. Difference in incision size (in mm)
Incidence of Adverse Events
Time frame: From surgical incision to end of surgery, assessed up to 120 minutes (intraoperative), and From end of surgery until postoperative day 30 (postoperative)
Number and type of ocular and non-ocular adverse events (serious and non-serious) recorded from initiation of the intra-ocular lens (IOL) implantation, both intraoperative and early postoperative period (up to 30 days). Percentage of participants with any AE
1 secondary outcome
Procedure Duration
Time frame: During surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No. The study does not include a plan to share individual participant data (IPD), as data will be anonymized and used solely for internal analysis and regulatory reporting
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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.
Adrián Hernández Martínez, MD, PhD principal investigator
OftalVist Sevilla
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 Lens Implantation, Intraocular, 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 4 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: looking for participants now, as of the sponsor's last update on 24 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrián Hernández Martínez, MD, PhD (+34 954 933 930, oft.ahm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Corneal Incision Size (time frame: Day of surgery (intraoperative)). 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 24 Aug 2025.