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The study aims to evaluate the clinical outcomes six months after implantation of the trifocal diffractive intraocular lens Asqelio Trifocal IOL TFLIO130C in healthy subjects submitted to non-traumatic cataract surgery.
This clinical performance will be assessed in terms of refractive error, visual performance at different distances, incidence of adverse events and complications following implantation, and patient satisfaction.
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Percentage of subjects with adverse events (Ocular and Not Ocular, Severe and Not Severe), including secondary surgical procedures | Six months after implantation |
| Refraction | Manifest refraction both monocular and binocularly using subjective methods | Six months after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected visual acuity for distance (4m) | Monocular visual acuity for distance (4m), without any additional correction, using ETDRS vision chart | Six months after implantation |
| Best-corrected visual acuity for distance (4m) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 50 years of age or older submitted to cataract surgery and implanted with the Asqelio Trifocal IOL TFLIO130C according to regular clinical practice
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OftalVist Jerez de la Frontera | Jerez de la Frontera | Cádiz | 11408 | Spain | ||
| OftalVist Alicante |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38780434 | Derived | Tana-Rivero P, Tana-Sanz P, Tana-Sanz S, Montes-Mico R, Cervino A. Recognition vs resolution charts for defocus curve determination in trifocal intraocular lenses. J Cataract Refract Surg. 2024 Sep 1;50(9):942-946. doi: 10.1097/j.jcrs.0000000000001491. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Monocular visual acuity for distance (4m), with the best correction for distance, using ETDRS vision chart
| Six months after implantation |
| Uncorrected visual acuity for intermediate | Monocular visual acuity for intermediate distance (60cm), without any additional correction, using ETDRS vision chart | Six months after implantation |
| Best-corrected visual acuity for intermediate | Monocular visual acuity for intermediate distance (60cm), with the best correction for distance, using ETDRS vision chart | Six months after implantation |
| Uncorrected visual acuity for near | Monocular visual acuity for near distance (40cm), without any additional correction, using ETDRS vision chart | Six months after implantation |
| Best-corrected visual acuity for near | Monocular visual acuity for near distance (40cm), with the best correction for distance, using ETDRS vision chart | Six months after implantation |
| Contrast sensitivity function (CSF) | CSF with best correction, with and without induced glare, using the Clinical Trial Suite | Six months after implantation |
| Defocus curve | Defocus curve of visual performance varying the stimulus vergence from -4.0 D to +1.0 D in 0.5 D steps with the best correction for distance | Six months after implantation |
| Alicante |
| 03015 |
| Spain |