An observational study in Cataract, sponsored by AST Products, Inc.. Status unknown at 1 site in Spain. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by AST Products, Inc. · Observational
The goal of this observational study is to assess the clinical outcomes of binocular implantation of Asqelio EDOF Toric IOLs in healthy cataract patients. The main questions it aims to answer are:
For this purpose, participants will be submitted to a comprehensive visual and refractive assessment, following common clinical practice, 3 months after binocular implantation of Asqelio EDOF Toric IOLs, and asked to complete visual symptoms and patient satisfaction questionnaires.
Healthy subjects submitted to bilateral cataract surgery with implantation of extended depth of focus IOLs according to common clinical practice
Exclusion Criteria:
Patient submitted to bilateral implantation of Asqelio EDOF Toric IOL
Uncorrected Monocular Visual acuity for distance
Visual acuity without additional correction determined at a distance of 4 m in LogMAR units
Time frame: 3 months after implantation
Uncorrected Monocular Visual acuity for intermediate distance
Visual acuity without additional correction determined at a distance of 67 cm in LogMAR units
Time frame: 3 months after implantation
Uncorrected Monocular Visual acuity for near distance
Visual acuity without additional correction determined at a distance of 40 cm in LogMAR units
Time frame: 3 months after implantation
Corrected Monocular Visual acuity for distance
Visual acuity with best correction determined at a distance of 4 m in LogMAR units
Time frame: 3 months after implantation
Corrected Monocular Visual acuity for intermediate distance
Visual acuity with best correction determined at a distance of 67 cm in LogMAR units
Time frame: 3 months after implantation
Corrected Monocular Visual acuity for near distance
Visual acuity with best correction determined at a distance of 40 cm in LogMAR units
Time frame: 3 months after implantation
Refractive error
Residual refractive error after implantation obtained by subjective refraction methods
Time frame: 3 months after implantation
Contrast sensitivity function under photopic conditions
Contrast sensitivity measured under photopic conditions for spatial frequencies of 3, 6, 12 and 18 cycles per degree using the Clinical Trial Suite in logCS units
Time frame: 3 months after implantation
Contrast sensitivity function under mesopic conditions
Contrast sensitivity measured under mesopic conditions for spatial frequencies of 1.5, 3, 6 and 12 cycles per degree using the Clinical Trial Suite in logCS units
Time frame: 3 months after implantation
Contrast sensitivity function under photopic conditions with glare
Contrast sensitivity measured under photopic conditions inducing glare, for spatial frequencies of 3, 6, 12 and 18 cycles per degree using the Clinical Trial Suite in logCS units
Time frame: 3 months after implantation
Contrast sensitivity function under mesopic conditions with glare
Contrast sensitivity measured under mesopic conditions inducing glare, for spatial frequencies of 1.5, 3, 6 and 12 cycles per degree using the Clinical Trial Suite in logCS units
Time frame: 3 months after implantation
Binocular defocus curve
Visual acuity in logMAR units under binocular conditions, determined varying the stimulus mergence using lenses from -4.00D to +2.00D in 0.50D steps and best refractive correction for distance
Time frame: 3 months after implantation
Aberrometry
Optical quality measured as Zernike coefficients for total Root Mean Square of Higher order aberrations, and Spherical aberrations, expressed in microns
Time frame: 3 months after implantation
Light distortion
Distortion of light as light distortion index, determined by means of the light distortion analyzer
Time frame: 3 months after implantation
Patient-reported visual symptoms
Incidence and severity of visual symptoms, determined by means of a visual symptoms questionnaire. Incidence will be scored in a scale from 1 (never) to 4 (always), severity from 1 (none) to 4 (severe), and bothersome rom 1(none) to 4 (a lot)
Time frame: 3 months after implantation
Patient-reported satisfaction
Level of satisfaction with vision and difficulty performing daily activities, determined by means of the CATQuest 9SF questionnaire, where items are scored in a scale from 1 (yes, a lot of difficulties) to 4 (no, no difficulties) and a "cannot decide" option. Satisfaction is scored from 1 (very unsatisfied) 4 (very satisfied) and a "cannot decide" option
Time frame: 3 months after surgery
Incidence of Adverse events
Percentage of patients presenting adverse events (ocular and non ocular, severe and not severe), including secondary surgical procedures
Time frame: 3 months after surgery
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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AST Products, Inc.