Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05790993
Other study ID # BIOLI012021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 20, 2022
Est. completion date July 20, 2022

Study information

Verified date February 2023
Source AST Products, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 20, 2022
Est. primary completion date July 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Spain OftalVist Alicante Alicante

Sponsors (1)

Lead Sponsor Collaborator
AST Products, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incision size after incision Determined using a Capsulorhexis Incision Gauge Set, in mm. Immediately after clear incision is performed
Primary Incision size before IOL implantation Determined using a Capsulorhexis Incision Gauge Set, in mm. Immediately after phacoemulsification is complete
Primary Incision size after IOL implantation Determined using a Capsulorhexis Incision Gauge Set, in mm. Immediately after IOL implantation
Primary 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 Best corrected visual acuity Visual acuity in LogMAR units with best correction for distance, evaluated at a distance of 4m using ETDRS optotype Before surgery
Secondary Best corrected visual acuity Visual acuity in LogMAR units with best correction for distance, evaluated at a distance of 4m using ETDRS optotype One month after surgery
Secondary Refractive error PreOp Manifest refraction before surgery in Diopters Before surgery
Secondary Refractive error PostOp Manifest refraction after surgery in Diopters One month after surgery
Secondary Intraocular Pressure (IOP) Preoperative intraocular pressure measured in mmHg Before surgery
Secondary Cataract grading Cataract grading before surgery using the LOCS III grading system Before surgery
See also
  Status Clinical Trial Phase
Completed NCT04998409 - Evaluation of a Spherical Hydrophilic Acrylic Intraocular Lens
Completed NCT04252716 - VISPER: Randomised Comparison of Two OVDs in Cataract Surgery
Recruiting NCT05110222 - Cataract Lens Hardness Based on Phaco Tip Resistance
Recruiting NCT04266847 - Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients N/A
Recruiting NCT04175951 - Tecnis Eyhance Versus Rayner RayOne Study N/A
Recruiting NCT04572334 - Eyhance Autorefraction Study N/A
Completed NCT04140383 - Cataract Surgery In Patients With Advanced Age
Active, not recruiting NCT04570579 - Impact of a Novel Extended Depth of Focus Intraocular Lens on Visual and Lifestyle Enhancement
Completed NCT05347615 - Achieving Hybrid Monovision By Paring Monofocal And EDOF Lens Technology
Completed NCT05129566 - Evaluation of Axial Stability of Two Models of Intraocular Lenses in Patients With an Eye Length More Than 26 mm N/A
Recruiting NCT05148507 - Optimization of the Ocular Surface Prior to Cataract Surgery Using PROKERA N/A
Completed NCT04655274 - Comparision of Visual Outcomes and Patient Satisfaction Between Two Diffractive Trifocal Intraocular Lenses
Completed NCT04255706 - Repeatability in Measurements of Two ssOCT and One OLCR Biometer N/A
Completed NCT05287269 - Ocular Coherence Tomography During Cataract Assessment
Completed NCT04545671 - Evaluation of a Trifocal Lens
Completed NCT04580550 - Axial Length Variability N/A
Recruiting NCT04265846 - Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of Presbyopia
Not yet recruiting NCT06429527 - Vision Test App and Questionnaire for 1-Week Post-Cataract Surgery Follow-Up: A Multi-Center Randomized Controlled Trial N/A
Completed NCT03970525 - Venturi and Peristaltic Based Phacoemulsification in Femtosecond Laser Cataract Surgery
Completed NCT04333056 - Comparison Between Two Ss-OCT Biometry