Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens

AST Products

Status: Completed

Conditions: Cataract

Study type: Observational

Funder types: Industry

Identifiers

NCT05776446

ASQT022022

Details and patient eligibility

About

The main objective of this study was to evaluate distance, intermediate, and near vision in patients who have undergone cataract extraction with bilateral implantation of a new hydrophobic trifocal diffractive intraocular lens (IOL) with a biospheric design, the Asqelio Trifocal IOL (AST Products, Inc., Billerica MA, USA), along with patient-reported outcomes (PRO). For that purpose the clinical information of 50 eyes from 25 patients was retrospectively analyzed 3 months after implantation

Enrollment: 25 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 50 years or older submitted to cataract surgery with binocular implantation of Asqelio Trifocal TFLIO130C IOL
• Seeking spectacle independence after surgery
• IOL power between +5.0D y +34.0D
• Transparent ocular media, except for the cataract prior to surgery.
• Potential postoperatory visual acuity of 20/25 or better, as assessed prior to surgery

Exclusion criteria

• Preoperatory corneal astigmatism greater than 1.0D
• Previous corneal surgery or trauma
• Irregular cornea (e.g. keratoconus)
• Choroidal hemorrhage
• Microftalmos
• Severe corneal dystrophy
• Uncontrolled or medically controlled glaucoma
• Clinically significant macular changes
• Severe concomitant ocular condition
• Cataract not age-related
• Severe optic nerve atrophy
• Diabetic retinopathy
• Ambyopia
• Extremely shallow anterior chamber
• Severe chronic uveitis
• Pregnancy or lactating
• Rubella
• Mature/dense cataract difficulting preoperatory eye fundus assessment
• Previous retinal detachment
• Concurrent participation in another investigation involving drugs or medical devices