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Completed

NCT Number: NCT05790993

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.

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Key information

Conditions

Cataract Senile

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

OftalVist Alicante

Alicante, 03015, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incision size after incision

    Time frame: Immediately after clear incision is performed

    Determined using a Capsulorhexis Incision Gauge Set, in mm.

  2. Incision size before IOL implantation

    Time frame: Immediately after phacoemulsification is complete

    Determined using a Capsulorhexis Incision Gauge Set, in mm.

  3. Incision size after IOL implantation

    Time frame: Immediately after IOL implantation

    Determined using a Capsulorhexis Incision Gauge Set, in mm.

  4. Adverse events

    Time frame: 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 outcomes

  1. Best corrected visual acuity

    Time frame: 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

    Time frame: 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

    Time frame: Before surgery

    Manifest refraction before surgery in Diopters

  4. Refractive error PostOp

    Time frame: One month after surgery

    Manifest refraction after surgery in Diopters

  5. Intraocular Pressure (IOP)

    Time frame: Before surgery

    Preoperative intraocular pressure measured in mmHg

  6. Cataract grading

    Time frame: Before surgery

    Cataract grading before surgery using the LOCS III grading system

Sponsors and collaborators

Lead sponsor

AST Products, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2023
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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