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

Sponsor
AST Products, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05790993
Collaborator
(none)
30
Enrollment
1
Location
30
Actual Duration (Days)
30.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Clinical Evaluation of the Bioli IOL Delivery System (BIOLI-D)
    Actual Study Start Date :
    Jun 20, 2022
    Actual Primary Completion Date :
    Jul 20, 2022
    Actual Study Completion Date :
    Jul 20, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Incision size after incision [Immediately after clear incision is performed]

      Determined using a Capsulorhexis Incision Gauge Set, in mm.

    2. Incision size before IOL implantation [Immediately after phacoemulsification is complete]

      Determined using a Capsulorhexis Incision Gauge Set, in mm.

    3. Incision size after IOL implantation [Immediately after IOL implantation]

      Determined using a Capsulorhexis Incision Gauge Set, in mm.

    4. 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)

    Secondary Outcome Measures

    1. Best corrected visual acuity [Before surgery]

      Visual acuity in LogMAR units with best correction for distance, evaluated at a distance of 4m using ETDRS optotype

    2. 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

    3. Refractive error PreOp [Before surgery]

      Manifest refraction before surgery in Diopters

    4. Refractive error PostOp [One month after surgery]

      Manifest refraction after surgery in Diopters

    5. Intraocular Pressure (IOP) [Before surgery]

      Preoperative intraocular pressure measured in mmHg

    6. Cataract grading [Before surgery]

      Cataract grading before surgery using the LOCS III grading system

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 OftalVist Alicante Alicante Spain 03015

    Sponsors and Collaborators

    • AST Products, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AST Products, Inc.
    ClinicalTrials.gov Identifier:
    NCT05790993
    Other Study ID Numbers:
    • BIOLI012021
    First Posted:
    Mar 30, 2023
    Last Update Posted:
    Mar 30, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Mar 30, 2023