An observational study in Cataract, sponsored by AST Products, Inc.. Recruiting at 3 sites in Spain. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by AST Products, Inc. · Observational
The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens in candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation.
Information will be obtained from patients operated by routine clinical practice with toric monofocal ASQELIO IOL in at least one eye. After confirmation of inclusion, the preoperative examination will be performed, and after surgery an evaluation will be performed the following day, one week, one month and three months after surgery.
In cataract surgery, the opacified lens is removed by phacoemulsification and replaced by an artificial IOL.The most common risk of cataract surgery is the development of a condition called posterior capsular opacification (PCO) that causes further deterioration of visual function. Toric intraocular lenses correct corneal astigmatism and avoid residual refractive errors in these subjects. For their efficacy in this refractive error correction, it is essential that, once implanted, these lenses are rotationally stable.The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens during the first 3 months after implantation.
All patients participating in the study are candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation model TLIO130 from AST Products, Inc., with CE marking.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 63 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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Adult subjects who are candidates for cataract surgery and implantation of toric monofocal ASQELIO IOL in at least one of their eyes.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult subjects undergoing cataract surgery by routine clinical practice with ASQELIO Toric Biaspheric Monofocal Lens in at least one eye.
Device: ASQELIO Toric Biaspheric Monofocal Lens
Intraocular lens implantation in cataract surgery
Rotational stability of the implant
Evaluated at each visit by analysis of slit-lamp backlight images, following the method described by Wolffsohn and Buckhurst. By means of backlighting, the IOL markings indicating the axis in which the astigmatic power is located will be observed and by image analysis it will be determined and quantified whether the lens has been rotated.
Time frame: During 3 months after IOL implantation
Visual acuity
Best corrected distance visual acuity in LogMAR units using the ETDRS chart
Time frame: During 3 months after IOL implantation
Refraction
Using subjective refraction methods.
Time frame: During 3 months after IOL implantation
Adverse events
Adverse events are obtained from solicited and spontaneous comments from the subjects and from observations made by the investigator.
Time frame: During 3 months after IOL implantation
Satisfaction and quality of vision questionnaire
Collected from solicited and spontaneous comments from the subjects, as well as the Catquest-9SF questionnaire, validated in Spanish. The subjective assessment of the quality of vision will be determined by an additional questionnaire about the presence of visual symptoms related to positive dysphotopsias (halos, glare and glare).
Time frame: During 3 months after IOL implantation
Plan to share: No
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AST Products, Inc.