Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens

Retrospective Study on the Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens With Follow-up at 3 Months

The main objective of this study was to evaluate distance, intermediate, and near vision in patients who have undergone cataract extraction with bilateral implantation of a new hydrophobic trifocal diffractive intraocular lens (IOL) with a biospheric design, the Asqelio Trifocal IOL (AST Products, Inc., Billerica MA, USA), along with patient-reported outcomes (PRO). For that purpose the clinical information of 50 eyes from 25 patients was retrospectively analyzed 3 months after implantation

Study Overview

• Status: Completed
• Conditions: Cataract

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Spain
  • Cordoba
    • Córdoba, Cordoba, Spain, 14012
      • Hospital La Arruzafa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects are regular clinic patients submitted to bilateral conventional cataract surgery by phacoemulsification, who wanted to correct their refractive error and presbyopia, and thus were implanted with the trifocal IOL subject to study by common clinical practice

Description

Inclusion Criteria:

• 50 years or older submitted to cataract surgery with binocular implantation of Asqelio Trifocal TFLIO130C IOL
• Seeking spectacle independence after surgery
• IOL power between +5.0D y +34.0D
• Transparent ocular media, except for the cataract prior to surgery.
• Potential postoperatory visual acuity of 20/25 or better, as assessed prior to surgery

Exclusion Criteria:

• Preoperatory corneal astigmatism greater than 1.0D
• Previous corneal surgery or trauma
• Irregular cornea (e.g. keratoconus)
• Choroidal hemorrhage
• Microftalmos
• Severe corneal dystrophy
• Uncontrolled or medically controlled glaucoma
• Clinically significant macular changes
• Severe concomitant ocular condition
• Cataract not age-related
• Severe optic nerve atrophy
• Diabetic retinopathy
• Ambyopia
• Extremely shallow anterior chamber
• Severe chronic uveitis
• Pregnancy or lactating
• Rubella
• Mature/dense cataract difficulting preoperatory eye fundus assessment
• Previous retinal detachment
• Concurrent participation in another investigation involving drugs or medical devices

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected distance visual acuity	Uncorrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Best-corrected distance visual acuity	Best-corrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Uncorrected intermediate visual acuity	Uncorrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Distance-corrected intermediate visual acuity	Distance-corrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Uncorrected near visual acuity	Uncorrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Distance-corrected near visual acuity	Distance-corrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units	3 months after implantation
Defocus curve	Binocular defocus curve with best correction for distance obtained varying mergence from -4.0D to +2.0D in 0.5D steps	3 months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manifest Refraction	Refraction determined monocularly by subjective refraction methods, in diopters	Preoperatively and 3 months after implantation
Adverse events	Percentage of subjects with adverse events (ocular and non ocular, severe and non severe), including secondary surgical interventions	3 months after implantation
Patient-reported outcomes CATQuest9SF	Patient reported outcomes were assessed by CATQuest9SF questionnaire	3 months after implantation
Patient-reported outcomes PRSIQ	Patient reported outcomes were assessed by patient-reported spectacle independence questionnaire (PRSIQ)	3 months after implantation
Patient-reported outcomes PRVSQ	Patient reported outcomes were assessed by the patient-reported visual symptoms questionnaire (PRVSQ)	3 months after implantation

Collaborators and Investigators

• Sponsor: AST Products, Inc.

Publications and helpful links

General Publications

• Cano-Ortiz A, Sanchez-Ventosa A, Gonzalez-Cruces T, Cerdan-Palacios D, Diaz-Mesa V, Gallego-Ordonez R, Galvez-Gomez T, Garcia Parrizas JA, Zurera Baena J, Villarrubia-Cuadrado A. Visual Performance, Satisfaction, and Spectacle Independence after Implantation of a New Hydrophobic Trifocal Intraocular Lens. J Clin Med. 2022 Oct 8;11(19):5931. doi: 10.3390/jcm11195931.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ASQT022022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No