Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens

The study aims to evaluate the clinical outcomes six months after implantation of the trifocal diffractive intraocular lens Asqelio Trifocal IOL TFLIO130C in healthy subjects submitted to non-traumatic cataract surgery.

This clinical performance will be assessed in terms of refractive error, visual performance at different distances, incidence of adverse events and complications following implantation, and patient satisfaction.

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03015
    • Oftalvist Alicante
  • Cádiz
    • Jerez de la Frontera, Cádiz, Spain, 11408
      • OftalVist Jerez de la Frontera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients 50 years of age or older submitted to cataract surgery and implanted with the Asqelio Trifocal IOL TFLIO130C according to regular clinical practice

Description

Inclusion Criteria:

• Patients submitted to cataract surgery and implanted with Asqelio Trifocal IOL TFLIO130C
• Patients signing a consent form
• Patients seeking spectacle-independence following surgery
• IOL power between +5.00 and +34.00 D
• Transparent intraocular media, except for the cataract prior to surgery, in both eyes
• Postoperatory potential visual acuity of 20/25 or better.

Exclusion Criteria:

• Preoperatory corneal astigmatism greater than 0.75D
• Patients not providing informed consent
• Previous corneal surgery or trauma
• Irregular cornea (i.e. keratoconus)
• Choroidal hemorrhage
• Microophthalmos
• Severe corneal dystrophy
• Uncontrolled or medically controlled glaucoma
• Clinically significant macular changes
• Severe concomitant ocular disease
• Not age-related cataract
• Severe optic nerve atrophy
• Diabetic retinopathy
• Ambyopia
• Extremely shallow anterior chamber
• Severe chronic uveitis
• Pregnant or lactating
• Rubella
• Mature/Dense cataract sifficulting preoperative fundus assessment
• Previous retinal detachment
• Concurrent participation in other investigation using drugs or clinical devices
• Expecting ocular surgery within the study period

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Percentage of subjects with adverse events (Ocular and Not Ocular, Severe and Not Severe), including secondary surgical procedures	Six months after implantation
Refraction	Manifest refraction both monocular and binocularly using subjective methods	Six months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected visual acuity for distance (4m)	Monocular visual acuity for distance (4m), without any additional correction, using ETDRS vision chart	Six months after implantation
Best-corrected visual acuity for distance (4m)	Monocular visual acuity for distance (4m), with the best correction for distance, using ETDRS vision chart	Six months after implantation
Uncorrected visual acuity for intermediate	Monocular visual acuity for intermediate distance (60cm), without any additional correction, using ETDRS vision chart	Six months after implantation
Best-corrected visual acuity for intermediate	Monocular visual acuity for intermediate distance (60cm), with the best correction for distance, using ETDRS vision chart	Six months after implantation
Uncorrected visual acuity for near	Monocular visual acuity for near distance (40cm), without any additional correction, using ETDRS vision chart	Six months after implantation
Best-corrected visual acuity for near	Monocular visual acuity for near distance (40cm), with the best correction for distance, using ETDRS vision chart	Six months after implantation
Contrast sensitivity function (CSF)	CSF with best correction, with and without induced glare, using the Clinical Trial Suite	Six months after implantation
Defocus curve	Defocus curve of visual performance varying the stimulus vergence from -4.0 D to +1.0 D in 0.5 D steps with the best correction for distance	Six months after implantation

Collaborators and Investigators

• Sponsor: AST Products, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: intraocular lens; cataract surgery; multifocal refractive correction
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ASQT012021

Drug and device information, study documents

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