An observational study in Cataract, sponsored by AST Products, Inc.. Completed at 1 site in Spain. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by AST Products, Inc. · Observational
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:
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's enrollment of 30 is below 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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patients of usual clinical practice who have undergone conventional cataract surgery by phacoemulsification and wish to eliminate their refractive error and correct their presbyopia
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients implanted bilterally with Asqelio Trifocal IOL
Other: Trifocal IOL implantation
Patients were implanted bilaterally with Asqelio Trifocal IOL 270±90 days before study visit
Residual refraction
Residual refractive error determined by subjective refraction procedures and expressed in diopters of spherical and cylindrical power
Time frame: 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
Time frame: 270±90 days from surgery
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)
Time frame: 270±90 days after surgery
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 270±90 days after surgery
Plan to share: Undecided
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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AST Products, Inc.