Cataract, Presbyopia Correction
Conditions
Keywords
intraocular lens, extended depth-of-focus, cataract surgery, optical quality
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
AST Products, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 50 years or older who have undergone cataract surgery with phacoemulsification or refractive lensectomy, with bilateral implantation of the Asqelio EDOF toric IOL model ETLIO130C/ETPIO130C with a cylinder value of 0.0 D, or the spherical monofocal J&J TECNIS 1-Piece IOL model ZCB00. * Patients who have signed the informed consent form. * Clear intraocular media, except for the presence of cataracts in both eyes prior to surgery. * Postoperative potential visual acuity of 20/25 or better
Exclusion criteria
* Preoperative corneal astigmatism greater than 1.00D. * Patients who do not provide informed consent. * Patients who do not understand the study procedure. * Previous corneal surgery or trauma. * Irregular cornea (e.g., keratoconus). * Choroidal hemorrhage. * Microphthalmos. * Severe corneal dystrophy. * Uncontrolled or medically controlled glaucoma. * Clinically significant macular changes. * Severe concomitant ocular disease. * Cataract unrelated to aging. * Severe optic nerve atrophy. * Diabetic retinopathy. * Proliferative diabetic retinopathy. * Amblyopia. * Extremely shallow anterior chamber. * Severe chronic uveitis. * Pregnant or breastfeeding. * Rubella. * Mature/dense cataract preventing preoperative fundus examination. * Previous retinal detachment. * Concurrent participation in another drug or clinical device investigation. * Expectation of needing another ocular surgery during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular dispersion index (OSI) | 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 |
| Higher order aberrations Root Mean Square (HORMS) | 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 |
| Ocular Spherical Aberration | Three months after intraocular lens implantation | Ocular spherical aberration was determined using Hartmann-Shack wavefront aberrometry. Measured in microns. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monocular visual acuity for distance vision with correction (CDVA) | 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 |
| Binocular Contrast sensitivity | Three months after intraocular lens implantation | Determined using the best-corrected Pelli-Robson test. Determined in logCS units |
| Defocus curve | 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 |
| Monocular visual acuity for distance vision without correction (UDVA) | 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 |
| Monocular visual acuity for intermediate vision with correction for distance (DCIVA) | 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 |
| Monocular visual acuity for intermediate vision without correction (UIVA) | 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 |
| Monocular visual acuity for near vision with correction for distance (DCNVA) | 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 |
| Monocular visual acuity for near vision without correction (UNVA) | 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 |
| Postoperative refractive error | Three months after intraocular lens implantation | Residual refractive error. Determined by manifest refraction. Measured in diopters |
| Monocular Contrast sensitivity | Three months after intraocular lens implantation | Determined using the best-corrected Pelli-Robson test. Determined in logCS units |
| CATQuest 9SF | 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. |
| Visual Symptoms questionnaire | 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 |
Countries
Spain
Outcome results
None listed