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

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 Overview

• Status: Completed
• Conditions: Cataract Senile

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03015
    • Oftalvist Alicante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with bilateral cataract submitted to cataract surgery by phacoemulsification and implantation of Asqelio trifocal TFLIO130C IOL using the BIOLI-D delivery system

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AST Products, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: BIOLI012021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No