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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06229756
• Other study ID #: ASQE012022
• Status: Active, not recruiting
• Start date: October 26, 2022
• Est. completion date: April 2024

Study information

• Verified date: January 2023
• Source: AST Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract

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	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Refractive error	Residual refractive error after implantation obtained by subjective refraction methods	3 months after implantation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Light distortion	Distortion of light as light distortion index, determined by means of the light distortion analyzer	3 months after implantation
Secondary	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
Secondary	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
Secondary	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