Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT06229756
Status:
UNKNOWN
Last Update Posted:
2024-01-29
First Post:
2024-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Results of Asqelio™ EDOF Toric Soft Hydrophobic Intraocular Lens After Cataract Surgery
Sponsor:
AST Products, Inc.
Organization:
Study Overview
Official Title:
Clinical Results of Asqelio™ EDOF Toric Soft Hydrophobic Intraocular Lens After Cataract Surgery
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: