Clinical Evaluation of the Bioli IOL Delivery System (BIOLI-D)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AST Products, Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Adverse events
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Mature/dense cataract difficulting fundas assessment preoperatively
- •Prior retinal detachment
- •Concurrent participation in another investigation with medication or clinical devices
Outcomes
Primary Outcomes
Adverse events
Time Frame: 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)
Incision size before IOL implantation
Time Frame: Immediately after phacoemulsification is complete
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Incision size after incision
Time Frame: Immediately after clear incision is performed
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Incision size after IOL implantation
Time Frame: Immediately after IOL implantation
Determined using a Capsulorhexis Incision Gauge Set, in mm.
Secondary Outcomes
- Cataract grading(Before surgery)
- Refractive error PreOp(Before surgery)
- Best corrected visual acuity(One month after surgery)
- Refractive error PostOp(One month after surgery)
- Intraocular Pressure (IOP)(Before surgery)