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

AST Products

Status: Active, not recruiting

Conditions: Cataract

Study type: Observational

Funder types: Industry

Identifiers

NCT06229756

ASQE012022

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 1 patient group

EDOF Toric

Description:

Patient submitted to bilateral implantation of Asqelio EDOF Toric IOL