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

Sponsor
AST Products, Inc.
Study ID
NCT07140029
Status
Recruiting
Apply to this trial

Conditions

  • Cataract
  • Lens Implantation, Intraocular

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 24, 2025
Start date
Aug 31, 2025
Status verified
Mar 2025
Primary completion
Nov 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: pioli™ rD
    Participants receiving the pioli™ preloaded injector with the rD model, used for IOL powers \< 25.5 diopters
  • Arm: pioli™ Plus rD
    Participants receiving the pioli™ Plus preloaded injector with the rD model, used for IOL powers \< 25.5 diopters
  • Arm: lioli™ <25.5D
    Participants receiving the lioli™ manually loaded injector for IOL powers \< 25.5 diopters
  • Arm: pioli™ rC
    Participants receiving the pioli™ preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters
  • Arm: pioli™ Plus rC
    Participants receiving the pioli™ Plus preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters
  • Arm: lioli™ ≥25.5D
    Participants receiving the lioli™ manually loaded injector for IOL powers ≥ 25.5 diopters

Primary Outcome Measure

Change in Corneal Incision Size [ Time Frame: Day of surgery (intraoperative) ]

Central Contacts

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