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NCT Number: NCT07140029

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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Lens Implantation, Intraocular

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clínica OftalVist Sevilla

Seville, Sevilla, 41018, Spain

Location status: Recruiting

Location contact

Adrian Hernandez Martinez, MD, PhD

CONTACT

[email protected]

+34 954 933 930

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Corneal Incision Size

    Time frame: Day of surgery (intraoperative)

    Measurement of the corneal incision before and after intraocular lens (IOL) insertion using each type of injector. Difference in incision size (in mm)

  2. Incidence of Adverse Events

    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)

    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

Secondary outcomes

  1. Procedure Duration

    Time frame: During surgery

    Time required to insert the IOL using each type of injector. Time in seconds (measured with a stopwatch)

Study contacts

Contact information is provided by the study sponsor or research team.

Adrián Hernández Martínez, MD, PhD

CONTACT

[email protected]

+34 954 933 930

Sponsors and collaborators

Lead sponsor

AST Products, Inc.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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