NCT07140029

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: AST Products, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract
• Lens Implantation, Intraocular

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2025-08-24
• Last updated: 2025-08-24

Locations

1 site across 1 country: Spain