An observational study in Cataract and Pseudophakia, sponsored by AST Products, Inc.. Enrolling by invitation at 1 site in Spain. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by AST Products, Inc. · Observational
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 150 is above the median of 89 across 475 observational studies indexed under Cataract.
Browse Cataract studies →AST Products, Inc. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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Adult subjects undergoing cataract surgery, implanted with ASQELIO monofocal model QLIO130C, and with a follow-up of more than 24 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: LIO ASQELIO TM monofocal QLIO130C
Intraocular lens (IOL) implant. All patients will have been treated as per standard clinical practice.
Incidence of Posterior capsular opacity
Incidence of PCO
Time frame: 24 months after IOL implantation
Intensity of Posterior capsular opacity
Intensity of PCO determined using LOCSIII Classification
Time frame: 24 months after IOL implantation
Visual acuity
Best corrected distance visual acuity in LogMAR units using the ETDRS chart
Time frame: At least 24 months after IOL implantation
Refraction
Residual refractive error in diopters determined objectively
Time frame: At least 24 months after IOL implantation
Incidence of Glistening
Incidence of IOL glistening
Time frame: 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).
Time frame: 24 months after IOL implantation
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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AST Products, Inc.