Clinical trial NCT05790993: Clinical Evaluation of the Bioli IOL Delivery System (BIOLI-D)
Official title: Clinical Evaluation of the Bioli IOL Delivery System (BIOLI-D)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Senile
Lead sponsor: AST Products, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.


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

Primary outcomes:
measure: Incision size after incision
timeFrame: Immediately after clear incision is performed
measure: Incision size before IOL implantation
timeFrame: Immediately after phacoemulsification is complete
measure: Incision size after IOL implantation
timeFrame: Immediately after IOL implantation
measure: Adverse events
timeFrame: During or after the surgical procedure
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: Before surgery
measure: Best corrected visual acuity
timeFrame: One month after surgery
measure: Refractive error PreOp
timeFrame: Before surgery
measure: Refractive error PostOp
timeFrame: One month after surgery
measure: Intraocular Pressure (IOP)
timeFrame: Before surgery
measure: Cataract grading
timeFrame: Before surgery
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: OftalVist Alicante
Study officials:
References: