Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design

N/AEnrolling By InvitationNCT06056154

AST Products, Inc.150 enrolled

Overview

The goal of this observational study is to learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months.

This is a retro-prospective, post-marketing observational study of a CE-marked medical device. The efficacy and safety of the Asqelio monofocal intraocular lens (IOL) model QLIO130C from AST Products, Inc, Billerica, USA, will be studied in patients implanted according to standard clinical practice. Twelve-month follow-up data will be collected from the medical records of the patients included in the study, and after 24 months they will be scheduled for a review.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Cataract Pseudophakia

Interventions

LIO ASQELIO TM monofocal QLIO130CDEVICE

Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with ASQELIO monofocal model QLIO130C. * Subjects for whom postoperative emmetropia (±0.5 D spherical equivalent) was planned. Exclusion Criteria: * Any pathology that reduces the potential Visual Acuity (VA) with its best correction beyond 0.30 logMAR. * Previous corneal surgery. * Rubella or surgery due to traumatic cataract. * Ocular trauma or refractive surgery. * Any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study

Locations (1)

Oftalmología Vistahermosa SL

Alicante, Spain

Outcomes

Primary Outcomes

Incidence of Posterior capsular opacity

Incidence of PCO

Time frame: 24 months after IOL implantation

Intensity of Posterior capsular opacity

Intensity of PCO determined using LOCSIII Classification

Time frame: 24 months after IOL implantation

Visual acuity

Best corrected distance visual acuity in LogMAR units using the ETDRS chart

Time frame: At least 24 months after IOL implantation

Secondary Outcomes

Refraction

Residual refractive error in diopters determined objectively

Time frame: At least 24 months after IOL implantation

Incidence of Glistening

Incidence of IOL glistening

Time frame: At least 24 months after IOL implantation

Intensity of Glistening

Intensity of IOL glistening. It will be evaluated by examining the center of the IOL optical zone with the pupil dilated using a slit lamp. The intensity of glistening will be graded as the number of glistening in the central region according to the following scale: 0 = absent, 1 = traceable (countable vacuoles), 2=moderate (low density of countless vacuoles), and 3=severe (high density of countless vacuoles).

Time frame: 24 months after IOL implantation

Data from ClinicalTrials.gov

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