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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Efficacy of the Hydrophobic Intraocular Lens AsqelioTM Monofocal With Biaspheric Design

Conditions
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Cataract, Pseudophakia

Intervention / Treatment
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* Device: LIO ASQELIO TM monofocal QLIO130C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing routine clinical practice with ASQELIOTM monofocal LIO model QLIO130C.<br>Data will be extracted retrospectively from their medical records and prospectively in a single follow-up visit. All procedures performed are according to standard clinical practice. | Device: LIO ASQELIO TM monofocal QLIO130C<br>* Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Posterior capsular opacity | Incidence of PCO | 24 months after IOL implantation | 
| Intensity of Posterior capsular opacity | Intensity of PCO determined using LOCSIII Classification | 24 months after IOL implantation | 
| Visual acuity | Best corrected distance visual acuity in LogMAR units using the ETDRS chart | At least 24 months after IOL implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refraction | Residual refractive error in diopters determined objectively | At least 24 months after IOL implantation | 
| Incidence of Glistening | Incidence of IOL glistening | 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). | 24 months after IOL implantation |