Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this observational study is to evaluate whether the Asqelio™ Trifocal intraocular lens (IOL) can improve refractive outcomes and optical quality in patients (aged ≥45 years) undergoing cataract surgery or clear lens exchange, including both male and female participants. The main questions it aims to answer are:
Researchers will not use a comparison group, as this is a post-marketing, single-arm observational study.
Participants will undergo bilateral implantation of the Asqelio™ Trifocal IOL during cataract or lens replacement surgery and attend a study follow-up exam approximately 270±90 days post-surgery.
Complete evaluations including:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trifocal | Patients implanted bilterally with Asqelio Trifocal IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifocal IOL implantation | Other | Patients were implanted bilaterally with Asqelio Trifocal IOL 270±90 days before study visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Residual refraction | Residual refractive error determined by subjective refraction procedures and expressed in diopters of spherical and cylindrical power | 270±90 days after surgery |
| Light Distortion Index | The distortion index is calculated as the ratio of the area of points missed by the subject and the total area explored using the Light Distortion Analyzer, and is expressed as a percentage | 270±90 days from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | The VA with its best correction placed under photopic conditions was determined monocularly at a distance of 4 meters (UDVA and BCDVA), 60 cm (UIVA and BDCIVA), 40 cm (UNVA and BDCNVA), using the optotype of letters Early Treatment Diabetic Retinopathy Study (ETDRS) | 270±90 days after surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
patients of usual clinical practice who have undergone conventional cataract surgery by phacoemulsification and wish to eliminate their refractive error and correct their presbyopia
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Baviera | Seville | Seville | 41013 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Binocular defocus curve |
Binocular defocus curve was obtained by varying the stimulus vergence from -4.0 D to +2.0 D in 0.5 D steps with the best correction for distance vision |
| 270±90 days after surgery |
| Contrast sensitivity | The spatial profile of the stimulus was configured to diplay sinusoidal patterns in a circular window with sharp or smoothed edges. The patient's task was to describe the orientation of the stimulus, which changes at random among three options: vertical (grating at 0°), right (15°), or left (-15°), using the Topcon CC-100 instrument | 270±90 days after surgery |
| Patient-Reported Outcomes - CATQuest9SF | 9-item questionnaire to determine patient activity limitations in daily life due to poor vision used due to its documented responsiveness in cataract surgery. It comprises 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. The questionnaire responses were scored using the Likert scale, from 1 for no difficulty/very satisfied, to 4 for very great difficulty/very dissatisfied. | 270±90 days after surgery |
| Patient-Reported Outcomes - Visual symptoms | A visual symptoms questionnaire explores the frequency, intensity and bothersome of 10 different and common visual symptoms. These symptoms are: Glare, Haloes, Starbursts, Foggy vision, Blurred vision, Distortion, Double vision, Fluctuation in vision, Difficulty focusing, and Difficulty judging distances or depth. A simulated image is shown to the patient to aid in the description of each of the symptoms, and they 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". The scoring of these responses ranges from 0 for Never/None to 3 for Very Often/Severe/A lot | 270±90 days after surgery |