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The goal of this observational study is to assess the clinical outcomes of binocular implantation of Asqelio EDOF Toric IOLs in healthy cataract patients. The main questions it aims to answer are:
For this purpose, participants will be submitted to a comprehensive visual and refractive assessment, following common clinical practice, 3 months after binocular implantation of Asqelio EDOF Toric IOLs, and asked to complete visual symptoms and patient satisfaction questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDOF Toric | Patient submitted to bilateral implantation of Asqelio EDOF Toric IOL |
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| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Monocular Visual acuity for distance | Visual acuity without additional correction determined at a distance of 4 m in LogMAR units | 3 months after implantation |
| Uncorrected Monocular Visual acuity for intermediate distance | Visual acuity without additional correction determined at a distance of 67 cm in LogMAR units | 3 months after implantation |
| Uncorrected Monocular Visual acuity for near distance | Visual acuity without additional correction determined at a distance of 40 cm in LogMAR units | 3 months after implantation |
| Corrected Monocular Visual acuity for distance | Visual acuity with best correction determined at a distance of 4 m in LogMAR units | 3 months after implantation |
| Corrected Monocular Visual acuity for intermediate distance | Visual acuity with best correction determined at a distance of 67 cm in LogMAR units | 3 months after implantation |
| Corrected Monocular Visual acuity for near distance | Visual acuity with best correction determined at a distance of 40 cm in LogMAR units | 3 months after implantation |
| Refractive error | Residual refractive error after implantation obtained by subjective refraction methods |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast sensitivity function under photopic conditions | Contrast sensitivity measured under photopic conditions for spatial frequencies of 3, 6, 12 and 18 cycles per degree using the Clinical Trial Suite in logCS units | 3 months after implantation |
| Contrast sensitivity function under mesopic conditions |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy subjects submitted to bilateral cataract surgery with implantation of extended depth of focus IOLs according to common clinical practice
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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 |
Contrast sensitivity measured under mesopic conditions for spatial frequencies of 1.5, 3, 6 and 12 cycles per degree using the Clinical Trial Suite in logCS units |
| 3 months after implantation |
| Contrast sensitivity function under photopic conditions with glare | Contrast sensitivity measured under photopic conditions inducing glare, for spatial frequencies of 3, 6, 12 and 18 cycles per degree using the Clinical Trial Suite in logCS units | 3 months after implantation |
| Contrast sensitivity function under mesopic conditions with glare | Contrast sensitivity measured under mesopic conditions inducing glare, for spatial frequencies of 1.5, 3, 6 and 12 cycles per degree using the Clinical Trial Suite in logCS units | 3 months after implantation |
| Binocular defocus curve | Visual acuity in logMAR units under binocular conditions, determined varying the stimulus mergence using lenses from -4.00D to +2.00D in 0.50D steps and best refractive correction for distance | 3 months after implantation |
| Aberrometry | Optical quality measured as Zernike coefficients for total Root Mean Square of Higher order aberrations, and Spherical aberrations, expressed in microns | 3 months after implantation |
| Light distortion | Distortion of light as light distortion index, determined by means of the light distortion analyzer | 3 months after implantation |
| Patient-reported visual symptoms | Incidence and severity of visual symptoms, determined by means of a visual symptoms questionnaire. Incidence will be scored in a scale from 1 (never) to 4 (always), severity from 1 (none) to 4 (severe), and bothersome rom 1(none) to 4 (a lot) | 3 months after implantation |
| Patient-reported satisfaction | Level of satisfaction with vision and difficulty performing daily activities, determined by means of the CATQuest 9SF questionnaire, where items are scored in a scale from 1 (yes, a lot of difficulties) to 4 (no, no difficulties) and a "cannot decide" option. Satisfaction is scored from 1 (very unsatisfied) 4 (very satisfied) and a "cannot decide" option | 3 months after surgery |
| Incidence of Adverse events | Percentage of patients presenting adverse events (ocular and non ocular, severe and not severe), including secondary surgical procedures | 3 months after surgery |