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

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.

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