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

Cataract Senile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05790993
• Other study ID #: BIOLI012021
• Status: Completed
• Start date: June 20, 2022
• Est. completion date: July 20, 2022

Study information

• Verified date: February 2023
• Source: AST Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 20, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Locations

Country	Name	City	State
Spain	OftalVist Alicante	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
AST Products, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incision size after incision	Determined using a Capsulorhexis Incision Gauge Set, in mm.	Immediately after clear incision is performed
Primary	Incision size before IOL implantation	Determined using a Capsulorhexis Incision Gauge Set, in mm.	Immediately after phacoemulsification is complete
Primary	Incision size after IOL implantation	Determined using a Capsulorhexis Incision Gauge Set, in mm.	Immediately after IOL implantation
Primary	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	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
Secondary	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
Secondary	Refractive error PreOp	Manifest refraction before surgery in Diopters	Before surgery
Secondary	Refractive error PostOp	Manifest refraction after surgery in Diopters	One month after surgery
Secondary	Intraocular Pressure (IOP)	Preoperative intraocular pressure measured in mmHg	Before surgery
Secondary	Cataract grading	Cataract grading before surgery using the LOCS III grading system	Before surgery