Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.

Study Overview
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Brief Summary
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The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens in candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation. Information will be obtained from patients operated by routine clinical practice with toric monofocal ASQELIO IOL in at least one eye. After confirmation of inclusion, the preoperative examination will be performed, and after surgery an evaluation will be performed the following day, one week, one month and three months after surgery.

Detailed Description
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In cataract surgery, the opacified lens is removed by phacoemulsification and replaced by an artificial IOL.The most common risk of cataract surgery is the development of a condition called posterior capsular opacification (PCO) that causes further deterioration of visual function. Toric intraocular lenses correct corneal astigmatism and avoid residual refractive errors in these subjects. For their efficacy in this refractive error correction, it is essential that, once implanted, these lenses are rotationally stable.The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens during the first 3 months after implantation. All patients participating in the study are candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation model TLIO130 from AST Products, Inc., with CE marking.

Official Title
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Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.

Conditions
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Cataract

Intervention / Treatment
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* Device: ASQELIO Toric Biaspheric Monofocal Lens


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 LIO ASQELIO. Subjects for whom postoperative emmetropia was planned (±0.5 D spherical equivalent) Exclusion Criteria: Preoperative corneal astigmatism less 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). Microphthalmos. Severe corneal dystrophy. Pregnant or breastfeeding'. Rubella Mature/dense cataract making eye bottom preoperative examination difficult. Previous retinal detachment. Concurrent participation in other research with drugs or clinical devices. Expect to require another eye surgery during the study period.

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 |
| --- | --- |
| Pseudophakic subjects implanted with the ASQELIO toric IOL<br>Adult subjects undergoing cataract surgery by routine clinical practice with ASQELIO Toric Biaspheric Monofocal Lens in at least one eye. | Device: ASQELIO Toric Biaspheric Monofocal Lens<br>* Intraocular lens implantation in cataract surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotational stability of the implant | Evaluated at each visit by analysis of slit-lamp backlight images, following the method described by Wolffsohn and Buckhurst. By means of backlighting, the IOL markings indicating the axis in which the astigmatic power is located will be observed and by image analysis it will be determined and quantified whether the lens has been rotated. | During 3 months after IOL implantation | 
| Visual acuity | Best corrected distance visual acuity in LogMAR units using the ETDRS chart | During 3 months after IOL implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refraction | Using subjective refraction methods. | During 3 months after IOL implantation | 
| Adverse events | Adverse events are obtained from solicited and spontaneous comments from the subjects and from observations made by the investigator. | During 3 months after IOL implantation | 
| Satisfaction and quality of vision questionnaire | Collected from solicited and spontaneous comments from the subjects, as well as the Catquest-9SF questionnaire, validated in Spanish. The subjective assessment of the quality of vision will be determined by an additional questionnaire about the presence of visual symptoms related to positive dysphotopsias (halos, glare and glare). | During 3 months after IOL implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract