Clinical Results of Asqelio Trifocal Toric Diffractive Intraocular Lens

The goal of this observational prospective clinical study is to learn about the clinical outcomes three months after binocular implantation of Asqelio Trifocal Toric IOL in 30 patients submitted to cataract surgery following standard clinical practice. The main questions it aims to answer are: How rotationally stable is the lens after implantation and how effective is in the correction of refractive astigmatism.

Additionally, the visual performance at different distances will be assessed, as well as the patient-reported outcomes.

Study Overview

• Status: Completed
• Conditions: Cataract

• Study Type: Observational
• Enrollment (Actual): 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

Regular clinical patients submitted to bilateral conventional cataract surgery using phacoemulsification and implanted with Asqelio Trifocal Toric to eliminate refractive error and presbyopia, also requiring toric correction to avoid residual astigmatism

Description

Inclusion Criteria:

• Patients submitted to cataract surgery with phacoemulsification with bilateral implantation of Asqelio Trifocal Toric IOL to avoid residual astigmatism
• Patient signing informed consent
• Clear intraocular media, except for cataracts in both eyes prior to surgery
• Monocular potential postoperative visual acuity of 20/25 or better

Exclusion Criteria:

• Corneal astigmatism lower than 0.75D
• 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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refraction	Manifest residual refraction after implantation of IOL using subjective refraction methods (D)	3 months after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected Visual acuity at distance	Visual acuity at 4m with refractive correction (LogMAR units)	3 months after implantation
Corrected Visual acuity at intermediate distance	Visual acuity at 60cm with refractive correction for distance (LogMAR units)	3 months after implantation
Corrected Visual acuity at near distance	Visual acuity at 40cm with refractive correction for distance (LogMAR units)	3 months after implantation
Uncorrected Visual acuity at distance	Visual acuity at 4m without correction (LogMAR units)	3 months after implantation
Uncorrected Visual acuity at intermediate distance	Visual acuity at 60cm without correction (LogMAR units)	3 months after implantation
Uncorrected Visual acuity at near distance	Visual acuity at 40cm without correction (LogMAR units)	3 months after implantation
Binocular defocus curve	Defocus curve obtained in binocular conditions from +2.00D to -4.00D vergence in 0.5 steps (LogMAR units)	3 months after implantation
Rotational stability	Change in IOL axis position determined with slit lamp (degrees)	3 months after implantation
Contrast sensitivity function	Contrast sensitivity determined with best correction for distance, under photopic and mesopic conditions, with and without induced glare, using the Clinical Trial Suite (CTS, M&S Technologies, Niles, IL, EEUU) (Log CS units)	3 months after implantation
Patient reported outcomes - Satisfaction	Patient reported outcomes obtained by means of the CATQuest9SF questionnaire. 9 items with 4 response options, ranging from 4 for "very great difficulty/very dissatisfied" to 1 for "no difficulty/very satisfied", and a "cannot decide" additional option, which is treated as missing data.	3 months after implantation
Patient reported outcomes - Visual Symptoms	Patient reported outcomes on incidence and intensity of visual symptoms obtained by means of a visual symptoms questionnaire. It explores the frequency, intensity and bothersome of 10 different and common visual symptoms. Patients are asked to respond with 4 response options to the frequency of the symptoms, from 1 for "Never" to 4 "Very often", the intensity of the symptom, from 1 for "None" to 4 for "Severe", and the level of bothersome of the symptom, from 1 for "None" to 4 for "A lot".	3 months after implantation

Collaborators and Investigators

• Sponsor: AST Products, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Actual): November 6, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: intraocular lens; cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ASQT042021

Drug and device information, study documents

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