Cataract Senile
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
AST Products, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incision size after incision | Immediately after clear incision is performed | Determined using a Capsulorhexis Incision Gauge Set, in mm. |
| Incision size before IOL implantation | Immediately after phacoemulsification is complete | Determined using a Capsulorhexis Incision Gauge Set, in mm. |
| Incision size after IOL implantation | Immediately after IOL implantation | Determined using a Capsulorhexis Incision Gauge Set, in mm. |
| Adverse events | During or after the surgical procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity | Before surgery | Visual acuity in LogMAR units with best correction for distance, evaluated at a distance of 4m using ETDRS optotype |
| Cataract grading | Before surgery | Cataract grading before surgery using the LOCS III grading system |
| Refractive error PreOp | Before surgery | Manifest refraction before surgery in Diopters |
| Refractive error PostOp | One month after surgery | Manifest refraction after surgery in Diopters |
| Intraocular Pressure (IOP) | Before surgery | Preoperative intraocular pressure measured in mmHg |
Countries
Spain
Outcome results
None listed