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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pseudophakic subjects implanted with the ASQELIO toric IOL | Adult subjects undergoing cataract surgery by routine clinical practice with ASQELIO Toric Biaspheric Monofocal Lens in at least one eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASQELIO Toric Biaspheric Monofocal Lens | Device | Intraocular lens implantation in cataract surgery |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects who are candidates for cataract surgery and implantation of toric monofocal ASQELIO IOL in at least one of their eyes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Cobo, Dr | Contact | +34963513304 | maria.cobo@oftalvist.es |
| Name | Affiliation | Role |
|---|---|---|
| Pedro Tañá, Dr | Oftalmología Vistahermosa SL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oftalvist Alicante | Recruiting | Alicante | 03013 | Spain |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 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 |
| OftalVist Madrid | Recruiting | Madrid | 28006 | Spain |
|
| OftalVist Valencia | Recruiting | Valencia | 46004 | Spain |
|