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

AST Products, Inc.120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Cataract Lens Implantation, Intraocular

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 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

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)

Secondary Outcomes

Procedure Duration

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

Time frame: During surgery