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

NCT05790993 | Completed

• 1 other identifier: BIOLI012021
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Best corrected visual acuity

  Before surgery

• Best corrected visual acuity

  One month after surgery

• Refractive error PreOp

  Before surgery

• Refractive error PostOp

  One month after surgery

• Intraocular Pressure (IOP)

  Before surgery

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AST Products, Inc.: lead

Study Sites (1)

OftalVist Alicante

Alicante, 03015, Spain

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 30, 2023
• Study Start: June 20, 2022
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: March 30, 2023

Record last verified: 2023-02

Locations

ES (1)