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

Completed

• Conditions: Cataract Senile

• Registration Number: NCT05790993
• Lead Sponsor: AST Products, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-20
• Primary Completion: 2022-07-20
• Study Completion: 2022-07-20
• Status Verified: 2023-02
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-03-17
• Last Update Submitted: 2023-03-17
• Study First Posted: 2023-03-30
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)
Incision size before IOL implantation	Immediately after phacoemulsification is complete	Determined using a Capsulorhexis Incision Gauge Set, in mm.
Incision size after incision	Immediately after clear incision is performed	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

OftalVist Alicante; 🇪🇸 Alicante, Spain