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

NCT07140029 | Recruiting

• 1 other identifier: PIOLI012022
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  From surgical incision to end of surgery, assessed up to 120 minutes (intraoperative), and From end of surgery until postoperative day 30 (postoperative)

Secondary Outcomes (1)

• Procedure Duration

  During surgery

Study Arms (6)

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AST Products, Inc.: lead

Study Sites (1)

Clínica OftalVist Sevilla

Seville, Sevilla, 41018, Spain

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Adrián Hernández Martínez, MD, PhD

  OftalVist Sevilla

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrián Hernández Martínez, MD, PhD

CONTACT

+34 954 933 930; oft.ahm@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: August 24, 2025
• Study Start: August 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)