Clinical Evaluation of the Bioli IOL Delivery System (BIOLI-D)

Study Overview
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Brief Summary
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Cataract surgery is one of the most frequent surgeries carried out in the world. After cataract extraction an intraocular lens (IOL) is implanted in order to compensate for the crystalline lens power and correct patient's vision. In order to allow cataract extraction and IOL insertion, during the surgery a small incision is performed by the surgeon. This incision is performed using surgical knives, and a smaller incisión is associated with less postoperatory inflammation, faster corneal wound healing, and faster visual recovery. Several studies reported the importance of smaller incisions to reduce the risk of surgically induced astigmatism. In order to implant the IOL through this small incision, the IOL must be preloaded in a injector that allows introducing the IOL eficiently and consistently. The manual injector BIOLI manufactured by AST Products (model D), CE approved, is designed specifically to allow the IOL insertion safely, precisely, and controllably. Among the main characteristics of this delivery system is its design to minimize the incision size widening while inserting the IOL. The present retrospective study aims to provide more information with regards to the clinical efficacy of the BIOLI-D delivery system for the implantation of the trifocal Asqelio TFLIO130C IOL in patients submitted to cataract surgery. This will be assessed by analyzing the change in incision size after IOL implantation and the incidence of adverse events during and after the procedure.

Official Title
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Clinical Evaluation of the Bioli IOL Delivery System (BIOLI-D)

Conditions
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Cataract Senile

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 50 years or older submitted to cataract surgery and implanted with Asqelio trifocal TFLIO130C IOL using the BIOLI-D delivery system. Patients submitted to bilateral cataract surgery. Transparent ocular media, other than the bilateral cataract. Exclusion Criteria: Preoperatory corneal astigmatism greater than 0.75D Corneal surgery or trauma prior to cataract surgery Irregular cornea Choroidal hemorrhage Microftalmos Severe corneal dystrophy Uncontrolled or medically controlled glaucoma Clinically significant macular changes Concomitant ocular disease Not age-related cataract Severe optic nerve atrophy Diabetic retinopathy Proliferative diabetic retinopathy Amblyopia Extremelly shallow anterior chamber Severe chronic uveitis Rubella Mature/dense cataract difficulting fundas assessment preoperatively Prior retinal detachment Concurrent participation in another investigation with medication or clinical devices

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision size after incision | Determined using a Capsulorhexis Incision Gauge Set, in mm. | Immediately after clear incision is performed | 
| Incision size before IOL implantation | Determined using a Capsulorhexis Incision Gauge Set, in mm. | Immediately after phacoemulsification is complete | 
| Incision size after IOL implantation | Determined using a Capsulorhexis Incision Gauge Set, in mm. | Immediately after IOL implantation | 
| Adverse events | Incidence of adverse events related to the use of the device, coded according to the Medical Dictionary for Regulatory Activities, and analyzed per eye (ocular), and per subject (non ocular) | During or after the surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | Visual acuity in LogMAR units with best correction for distance, evaluated at a distance of 4m using ETDRS optotype | Before surgery | 
| Best corrected visual acuity | Visual acuity in LogMAR units with best correction for distance, evaluated at a distance of 4m using ETDRS optotype | One month after surgery | 
| Refractive error PreOp | Manifest refraction before surgery in Diopters | Before surgery | 
| Refractive error PostOp | Manifest refraction after surgery in Diopters | One month after surgery | 
| Intraocular Pressure (IOP) | Preoperative intraocular pressure measured in mmHg | Before surgery | 
| Cataract grading | Cataract grading before surgery using the LOCS III grading system | Before surgery |