Comparison of Lioli™, Pioli™, and Pioli™ Plus intraocular lens injectors
Official title: Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus
Run by AST Products, Inc. · NCT07140029 · Data updated 2026-11-12
This will test whether three different IOL injectors—Lioli™, Pioli™, and Pioli™ Plus—change corneal incision size or complication rates for people aged 40 and older having cataract surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | AST Products, Inc. Industry-sponsored |
| Locations | 1 site (Seville, Sevilla) |
| Status | Recruiting |
| Started | August 2025 |
| Main results expected | November 2025 |
| Study ends | December 2025 |
| Registry record updated | August 24, 2025 |
| Trial ID | NCT07140029 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults aged 40 or older scheduled for phacoemulsification with implantation of an Asqelio™ monofocal IOL and who have clear intraocular media besides cataract and corneal astigmatism ≤1.0 D.
✕Probably not a fit
Patients with prior corneal surgery, irregular corneas, significant retinal or optic nerve disease, advanced diabetic retinopathy, very shallow anterior chambers, pregnancy, or other listed exclusion criteria are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows patients aged 40 and older who undergo routine phacoemulsification cataract surgery with an Asqelio™ monofocal IOL using one of three injector systems. Participants are assigned to use either a manually loaded injector (Lioli™) or one of two preloaded systems (Pioli™ or Pioli™ Plus) and have measurements taken before and after surgery, including incision size and visual tests. Investigators will record intraoperative and postoperative complications and compare outcomes between the injector groups. The study is conducted at Clínica OftalVist Sevilla and uses standard clinical follow-up to capture safety and surgical performance data.
Why it matters
Potential benefit: If successful, the findings could show that a particular injector reduces incision size or complications, which may shorten recovery and improve surgical safety.
How similar studies have gone: Prior device reports and small comparative series have suggested preloaded injectors can reduce handling and incision manipulation, but head-to-head comparative data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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
Where it's running
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Clínica OftalVist Sevilla
Seville, Sevilla, Spain Recruiting
Study contacts
- Principal investigator: Adrián Hernández Martínez, MD, PhD — OftalVist Sevilla
- Study coordinator: Adrián Hernández Martínez, MD, PhD
- Email: oft.ahm@gmail.com
- Phone: +34 954 933 930
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.