Clinical Results of Asqelio™ EDOF Toric Soft Hydrophobic Intraocular Lens After Cataract Surgery

The goal of this observational study is to assess the clinical outcomes of binocular implantation of Asqelio EDOF Toric IOLs in healthy cataract patients. The main questions it aims to answer are:

• What is the visual performance at different distances 3 months after implantation of Asqelio EDOF Toric in both eyes?
• What is the amount of residual refractive error following the implantation?
• What is the contrast sensitivity of patients 3 months after implantation of Asqelio EDOF Toric in both eyes?
• What is the optical quality of the eye implanted with Asqelio EDOF Toric IOL?
• What is the incidence and severity of visual symptoms after implantation of Asqelio EDOF Toric?
• What is the level of patient satisfaction after implantation of Asqelio EDOF Toric?

For this purpose, participants will be submitted to a comprehensive visual and refractive assessment, following common clinical practice, 3 months after binocular implantation of Asqelio EDOF Toric IOLs, and asked to complete visual symptoms and patient satisfaction questionnaires.

Study Overview

• Status: Active, not recruiting
• Conditions: Cataract

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

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03015
    • Oftalvist Alicante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects submitted to bilateral cataract surgery with implantation of extended depth of focus IOLs according to common clinical practice

Description

Inclusion Criteria:

• Patients 50 years old or more submitted to bilateral cataract surgery and implanted with Asqelio EDOF toric IOL, with cylinder value of 0.0 D.
• Patients signing informed consent
• Transparent media except for the cataracts
• Potential postoperatoria visual acuity of 20/25 or better

Exclusion Criteria:

• Preoperative corneal astigmatism greater than 1.00D
• Patients who do not provide informed consent
• Patients who do not understand the study procedure
• Previous corneal surgery or trauma
• Irregular cornea (e.g. keratoconus)
• Choroidal hemorrhage
• Microphtalmos
• Severe corneal dystrophy
• Uncontrolled or medically controlled glaucoma
• Clinically significant macular changes
• Concomitant severe eye disease
• Non-age-related cataract
• Severe optic nerve atrophy
• Diabetic retinopathy
• Proliferative diabetic retinopathy
• Amblyopia
• Extremely shallow anterior camera
• Severe chronic uveítis
• Pregnant or nursing
• Rubella
• Mature/dense cataract that makes it difficult to examine the fundus preoperatively.
• Previous retinal detachment
• Concurrent participation in other research with drugs or clinical devices
• Expect to require another eye surgery during the study period

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
EDOF Toric; Patient submitted to bilateral implantation of Asqelio EDOF Toric IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Monocular Visual acuity for distance	Visual acuity without additional correction determined at a distance of 4 m in LogMAR units	3 months after implantation
Uncorrected Monocular Visual acuity for intermediate distance	Visual acuity without additional correction determined at a distance of 67 cm in LogMAR units	3 months after implantation
Uncorrected Monocular Visual acuity for near distance	Visual acuity without additional correction determined at a distance of 40 cm in LogMAR units	3 months after implantation
Corrected Monocular Visual acuity for distance	Visual acuity with best correction determined at a distance of 4 m in LogMAR units	3 months after implantation
Corrected Monocular Visual acuity for intermediate distance	Visual acuity with best correction determined at a distance of 67 cm in LogMAR units	3 months after implantation
Corrected Monocular Visual acuity for near distance	Visual acuity with best correction determined at a distance of 40 cm in LogMAR units	3 months after implantation
Refractive error	Residual refractive error after implantation obtained by subjective refraction methods	3 months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity function under photopic conditions	Contrast sensitivity measured under photopic conditions for spatial frequencies of 3, 6, 12 and 18 cycles per degree using the Clinical Trial Suite in logCS units	3 months after implantation
Contrast sensitivity function under mesopic conditions	Contrast sensitivity measured under mesopic conditions for spatial frequencies of 1.5, 3, 6 and 12 cycles per degree using the Clinical Trial Suite in logCS units	3 months after implantation
Contrast sensitivity function under photopic conditions with glare	Contrast sensitivity measured under photopic conditions inducing glare, for spatial frequencies of 3, 6, 12 and 18 cycles per degree using the Clinical Trial Suite in logCS units	3 months after implantation
Contrast sensitivity function under mesopic conditions with glare	Contrast sensitivity measured under mesopic conditions inducing glare, for spatial frequencies of 1.5, 3, 6 and 12 cycles per degree using the Clinical Trial Suite in logCS units	3 months after implantation
Binocular defocus curve	Visual acuity in logMAR units under binocular conditions, determined varying the stimulus mergence using lenses from -4.00D to +2.00D in 0.50D steps and best refractive correction for distance	3 months after implantation
Aberrometry	Optical quality measured as Zernike coefficients for total Root Mean Square of Higher order aberrations, and Spherical aberrations, expressed in microns	3 months after implantation
Light distortion	Distortion of light as light distortion index, determined by means of the light distortion analyzer	3 months after implantation
Patient-reported visual symptoms	Incidence and severity of visual symptoms, determined by means of a visual symptoms questionnaire. Incidence will be scored in a scale from 1 (never) to 4 (always), severity from 1 (none) to 4 (severe), and bothersome rom 1(none) to 4 (a lot)	3 months after implantation
Patient-reported satisfaction	Level of satisfaction with vision and difficulty performing daily activities, determined by means of the CATQuest 9SF questionnaire, where items are scored in a scale from 1 (yes, a lot of difficulties) to 4 (no, no difficulties) and a "cannot decide" option. Satisfaction is scored from 1 (very unsatisfied) 4 (very satisfied) and a "cannot decide" option	3 months after surgery
Incidence of Adverse events	Percentage of patients presenting adverse events (ocular and non ocular, severe and not severe), including secondary surgical procedures	3 months after surgery

Collaborators and Investigators

• Sponsor: AST Products, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification
• Other Study ID Numbers: ASQE012022

Drug and device information, study documents

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