An observational study in Cataract and Lens Implantation, Intraocular, sponsored by AST Products, Inc.. Recruiting at 1 site in Spain. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by AST Products, Inc. · Observational
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:
Participants will:
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 120 is above the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →AST Products, Inc. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving the pioli™ preloaded injector with the rD model, used for IOL powers \< 25.5 diopters
Participants receiving the pioli™ Plus preloaded injector with the rD model, used for IOL powers \< 25.5 diopters
Participants receiving the lioli™ manually loaded injector for IOL powers \< 25.5 diopters
Participants receiving the pioli™ preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters
Participants receiving the pioli™ Plus preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters
Participants receiving the lioli™ manually loaded injector for IOL powers ≥ 25.5 diopters
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)
Time frame: 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
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)
Procedure Duration
Time required to insert the IOL using each type of injector. Time in seconds (measured with a stopwatch)
Time frame: During surgery
Plan to share: 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
No publications or documents are linked to this record.
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AST Products, Inc.