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

AST Products

Status: Enrolling

Conditions: Cataract; Lens Implantation, Intraocular

Study type: Observational

Funder types: Industry

Identifiers

NCT07140029

PIOLI012022

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 6 patient groups

pioli™ rD

Description:

Participants receiving the pioli™ preloaded injector with the rD model, used for IOL powers \< 25.5 diopters

pioli™ Plus rD

Description:

Participants receiving the pioli™ Plus preloaded injector with the rD model, used for IOL powers \< 25.5 diopters

lioli™ <25.5D

Description:

Participants receiving the lioli™ manually loaded injector for IOL powers \< 25.5 diopters

pioli™ rC

Description:

Participants receiving the pioli™ preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters

pioli™ Plus rC

Description:

Participants receiving the pioli™ Plus preloaded injector with the rC model, used for IOL powers ≥ 25.5 diopters

lioli™ ≥25.5D

Description:

Participants receiving the lioli™ manually loaded injector for IOL powers ≥ 25.5 diopters