Visual Quality and Performance of Eyes With Asqelio™ EDoF Toric Lenses

Completed

• Conditions: Cataract; Presbyopia Correction

• Registration Number: NCT06707545
• Lead Sponsor: AST Products, Inc.

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.

Study Timeline

• Study Start: 2023-01-11
• Primary Completion: 2024-05-14
• Study Completion: 2024-05-14
• Status Verified: 2024-11
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Last Update Submitted: 2024-11-24
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 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
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
CATQuest 9SF	Three months after surgery	Patient-reported outcomes on satisfaction and difficulty performing task after surgery. Obtained for the EDOF IOL group only
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
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 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

Trial Locations

Locations (1)

Hospital La Arruzafa; 🇪🇸 Córdoba, Cordoba, Spain