Cataract, Pseudophakia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICELIO ASQELIO TM monofocal QLIO130C
Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.
Sponsors
AST Products, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with ASQELIO monofocal model QLIO130C. * Subjects for whom postoperative emmetropia (±0.5 D spherical equivalent) was planned.
Exclusion criteria
* Any pathology that reduces the potential Visual Acuity (VA) with its best correction beyond 0.30 logMAR. * Previous corneal surgery. * Rubella or surgery due to traumatic cataract. * Ocular trauma or refractive surgery. * Any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Posterior capsular opacity | 24 months after IOL implantation | Incidence of PCO |
| Intensity of Posterior capsular opacity | 24 months after IOL implantation | Intensity of PCO determined using LOCSIII Classification |
| Visual acuity | At least 24 months after IOL implantation | Best corrected distance visual acuity in LogMAR units using the ETDRS chart |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Refraction | At least 24 months after IOL implantation | Residual refractive error in diopters determined objectively |
| Incidence of Glistening | At least 24 months after IOL implantation | Incidence of IOL glistening |
| Intensity of Glistening | 24 months after IOL implantation | 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). |
Countries
Spain
Outcome results
None listed