Clinical Results of Asqelio Trifocal Toric Diffractive Intraocular Lens

AST Products

Status: Completed

Conditions: Cataract

Study type: Observational

Funder types: Industry

Identifiers

NCT06190925

ASQT042021

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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