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
Not provided
Not provided
The goal of this observational study is to learn about the Asqelio monofocal intraocular lens (IOL) model QLIO130C in patients undergoing cataract surgery. The aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months.
This is a retro-prospective, post-marketing observational study of a CE-marked medical device. The efficacy and safety of the Asqelio monofocal intraocular lens (IOL) model QLIO130C from AST Products, Inc, Billerica, USA, will be studied in patients implanted according to standard clinical practice. Twelve-month follow-up data will be collected from the medical records of the patients included in the study, and after 24 months they will be scheduled for a review.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing routine clinical practice with ASQELIOTM monofocal LIO model QLIO130C. | Data will be extracted retrospectively from their medical records and prospectively in a single follow-up visit. All procedures performed are according to standard clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIO ASQELIO TM monofocal QLIO130C | Device | Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Posterior capsular opacity | Incidence of PCO | 24 months after IOL implantation |
| Intensity of Posterior capsular opacity | Intensity of PCO determined using LOCSIII Classification | 24 months after IOL implantation |
| Visual acuity | Best corrected distance visual acuity in LogMAR units using the ETDRS chart | At least 24 months after IOL implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Refraction | Residual refractive error in diopters determined objectively | At least 24 months after IOL implantation |
| Incidence of Glistening | Incidence of IOL glistening |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult subjects undergoing cataract surgery, implanted with ASQELIO monofocal model QLIO130C, and with a follow-up of more than 24 months.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oftalmología Vistahermosa SL | Alicante | 46026 | Spain |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
| At least 24 months after IOL implantation |
| Intensity of Glistening | Intensity of IOL glistening. It will be evaluated by examining the center of the IOL optical zone with the pupil dilated using a slit lamp. The intensity of glistening will be graded as the number of glistening in the central region according to the following scale: 0 = absent, 1 = traceable (countable vacuoles), 2=moderate (low density of countless vacuoles), and 3=severe (high density of countless vacuoles). | 24 months after IOL implantation |