Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus

Status: Recruiting
Location: See location...
Study Type: Observational
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Spain
Clínica OftalVist Sevilla
RECRUITING
Seville
Contact Information
Primary
Adrián Hernández Martínez, MD, PhD
oft.ahm@gmail.com
+34 954 933 930
Time Frame
Start Date: 2025-08
Estimated Completion Date: 2025-12
Participants
Target number of participants: 120
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: AST Products, Inc.

This content was sourced from clinicaltrials.gov