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The goal of this observational prospective clinical study is to learn about the clinical outcomes three months after binocular implantation of Asqelio Trifocal Toric IOL in 30 patients submitted to cataract surgery following standard clinical practice. The main questions it aims to answer are: How rotationally stable is the lens after implantation and how effective is in the correction of refractive astigmatism.
Additionally, the visual performance at different distances will be assessed, as well as the patient-reported outcomes.
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| Measure | Description | Time Frame |
|---|---|---|
| Refraction | Manifest residual refraction after implantation of IOL using subjective refraction methods (D) | 3 months after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Corrected Visual acuity at distance | Visual acuity at 4m with refractive correction (LogMAR units) | 3 months after implantation |
| Corrected Visual acuity at intermediate distance | Visual acuity at 60cm with refractive correction for distance (LogMAR units) |
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Inclusion Criteria:
Exclusion Criteria:
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Regular clinical patients submitted to bilateral conventional cataract surgery using phacoemulsification and implanted with Asqelio Trifocal Toric to eliminate refractive error and presbyopia, also requiring toric correction to avoid residual astigmatism
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OftalVist Alicante | Alicante | 03015 | Spain |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 3 months after implantation |
| Corrected Visual acuity at near distance | Visual acuity at 40cm with refractive correction for distance (LogMAR units) | 3 months after implantation |
| Uncorrected Visual acuity at distance | Visual acuity at 4m without correction (LogMAR units) | 3 months after implantation |
| Uncorrected Visual acuity at intermediate distance | Visual acuity at 60cm without correction (LogMAR units) | 3 months after implantation |
| Uncorrected Visual acuity at near distance | Visual acuity at 40cm without correction (LogMAR units) | 3 months after implantation |
| Binocular defocus curve | Defocus curve obtained in binocular conditions from +2.00D to -4.00D vergence in 0.5 steps (LogMAR units) | 3 months after implantation |
| Rotational stability | Change in IOL axis position determined with slit lamp (degrees) | 3 months after implantation |
| Contrast sensitivity function | Contrast sensitivity determined with best correction for distance, under photopic and mesopic conditions, with and without induced glare, using the Clinical Trial Suite (CTS, M&S Technologies, Niles, IL, EEUU) (Log CS units) | 3 months after implantation |
| Patient reported outcomes - Satisfaction | Patient reported outcomes obtained by means of the CATQuest9SF questionnaire. 9 items with 4 response options, ranging from 4 for "very great difficulty/very dissatisfied" to 1 for "no difficulty/very satisfied", and a "cannot decide" additional option, which is treated as missing data. | 3 months after implantation |
| Patient reported outcomes - Visual Symptoms | Patient reported outcomes on incidence and intensity of visual symptoms obtained by means of a visual symptoms questionnaire. It explores the frequency, intensity and bothersome of 10 different and common visual symptoms. Patients are asked to respond with 4 response options to the frequency of the symptoms, from 1 for "Never" to 4 "Very often", the intensity of the symptom, from 1 for "None" to 4 for "Severe", and the level of bothersome of the symptom, from 1 for "None" to 4 for "A lot". | 3 months after implantation |