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.
Study Type
OBSERVATIONAL
Enrollment
30
OftalVist Alicante
Alicante, Spain
Incision size after incision
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Time frame: Immediately after clear incision is performed
Incision size before IOL implantation
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Time frame: Immediately after phacoemulsification is complete
Incision size after IOL implantation
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Time frame: 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)
Time frame: During or after the surgical procedure
Best corrected visual acuity
Visual acuity in LogMAR units with best correction for distance, evaluated at a distance of 4m using ETDRS optotype
Time frame: 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
Time frame: One month after surgery
Refractive error PreOp
Manifest refraction before surgery in Diopters
Time frame: Before surgery
Refractive error PostOp
Manifest refraction after surgery in Diopters
Time frame: One month after surgery
Intraocular Pressure (IOP)
Preoperative intraocular pressure measured in mmHg
Time frame: Before surgery
Cataract grading
Cataract grading before surgery using the LOCS III grading system
Time frame: Before surgery
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