Hospital La Arruzafa
Córdoba, Cordoba, 14012, Spain
NCT Number: NCT06707545
This study evaluates the optical quality and clinical performance of the Asqelio™ EDOF Toric intraocular lens (IOL) in patients undergoing cataract surgery or refractive lensectomy. The Asqelio™ EDOF Toric IOL aims to provide improved vision at various distances and correct astigmatism compared to monofocal IOLs. Postoperative outcomes, including visual clarity, refractive correction, and patient satisfaction, will be assessed three months after surgery.
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Notify Me50 year and older
All sexes
Observational
Córdoba, Cordoba, 14012, Spain
Cataract surgery is one of the most common procedures worldwide, typically involving the replacement of the cloudy natural lens with an intraocular lens (IOL). Traditional monofocal IOLs correct vision for a single distance but do not address intermediate or near vision, leading to dependence on glasses. The Asqelio™ EDOF Toric IOL is designed to provide extended depth of focus, smoother transitions across distances, and astigmatism correction, potentially enhancing overall visual quality and reducing the need for glasses.
This study compares the optical performance and patient outcomes of the Asqelio™ EDOF Toric IOL with those of monofocal IOLs. Key measures include optical quality, visual acuity at multiple distances, refractive correction, and patient-reported satisfaction. Results will be collected during a three-month postoperative follow-up. The findings aim to inform the effectiveness of the Asqelio™ EDOF Toric IOL in improving visual outcomes and quality of life for patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Three months after intraocular lens implantation
OSI value represents the ratio of the amount of light within an annular area of 12 to 20 arc minute and the light corresponding to a circular area of one minute of arc around the central peak. Determined using the OQAS II double pass system
Time frame: Three months after intraocular lens implantation
The RMS value for higher order aberrations is calculated from the wavefront error map, determined using Hartmann-Shack wavefront aberrometry. Measured in microns
Time frame: Three months after intraocular lens implantation
Ocular spherical aberration was determined using Hartmann-Shack wavefront aberrometry. Measured in microns.
Time frame: Three months after intraocular lens implantation
The VA with its best correction placed under photopic conditions was determined monocularly at a distance of 4 meters. Measured in LogMAR units
Time frame: Three months after intraocular lens implantation
The VA without correction under photopic conditions was determined monocularly at a distance of 4 meters. Measured in LogMAR units
Time frame: Three months after intraocular lens implantation
The VA with its best correction placed under photopic conditions was determined monocularly at a distance of 67 centimeters. Measured in LogMAR units
Time frame: Three months after intraocular lens implantation
The VA without correction under photopic conditions was determined monocularly at a distance of 67 centimeters. Measured in LogMAR units
Time frame: Three months after intraocular lens implantation
The VA with its best correction placed under photopic conditions was determined monocularly at a distance of 40 centimeters. Measured in LogMAR units
Time frame: Three months after intraocular lens implantation
The VA without correction under photopic conditions was determined monocularly at a distance of 40 centimeters. Measured in LogMAR units
Time frame: Three months after intraocular lens implantation
Residual refractive error. Determined by manifest refraction. Measured in diopters
Time frame: Three months after intraocular lens implantation
Determined using the best-corrected Pelli-Robson test. Determined in logCS units
Time frame: Three months after intraocular lens implantation
Determined using the best-corrected Pelli-Robson test. Determined in logCS units
Time frame: Three months after intraocular lens implantation
Binocular defocus curve obtained for the EDOF IOL group by varying the vergence of the stimulus from -4.0 D to +2.0 D in steps of 0.5 D with the best correction for distance vision
Time frame: Three months after surgery
Patient-reported outcomes on satisfaction and difficulty performing task after surgery. Obtained for the EDOF IOL group only. Each of the 9 items is scored using the Likert scale, from 1 for no difficulty/very satisfied, to 4 for very great difficulty/very dissatisfied, with higher scores indicating worse visual function.
Time frame: Three months after surgery
Questionnaire exploring the frequency, intensity and bothersome of different visual symptoms. Obtained from the subjects in the EDOF IOL group only.The scoring of these responses ranges from 0 for Never/None to 3 for Very Often/Severe/A lot, with higher scores indicating worse quality of vision
AST Products, Inc.
Industry
In Situ Analysis of the Optical Quality and Visual Solvency of Eyes Implanted Bilaterally With the Asqelio™ EDoF Toric Extended-focus Intraocular Lens
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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