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

NCT ID: NCT05790993

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2022-07-20

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AST Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OftalVist Alicante

Alicante, , Spain

Countries

Spain

Other Identifiers

BIOLI012021

Identifier Type: -

Identifier Source: org_study_id