Clinical trial NCT06707545: Visual Quality and Performance of Eyes With Asqelio™ EDoF Toric Lenses
Official title: In Situ Analysis of the Optical Quality and Visual Solvency of Eyes Implanted Bilaterally With the Asqelio™ EDoF Toric Extended-focus Intraocular Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Presbyopia Correction
Keywords: intraocular lens
extended depth-of-focus
cataract surgery
optical quality
Lead sponsor: AST Products, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients participating in the study will have been implanted with either the spherical monofocal intraocular lens (IOL) J\&J TECNIS® 1-Piece model ZCB00 (Control Group), manufactured by Johnson \& Johnson Vision (Jacksonville, USA), or the extended depth of focus (EDOF) toric IOL Asqelio™ model ETLIO130C/ETPIO130C (Study Group) from AST Products, Inc., Billerica, USA, with a cylinder value of 0.0 D. All patients will be treated according to standard clinical practice, meaning that both the preoperative evaluation and the surgical procedure for IOL implantation will have been completed prior to their inclusion in the study

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ocular dispersion index (OSI)
timeFrame: Three months after intraocular lens implantation
measure: Higher order aberrations Root Mean Square (HORMS)
timeFrame: Three months after intraocular lens implantation
measure: Ocular Spherical Aberration
timeFrame: Three months after intraocular lens implantation
Secondary outcomes:
measure: Monocular visual acuity for distance vision with correction (CDVA)
timeFrame: Three months after intraocular lens implantation
measure: Monocular visual acuity for distance vision without correction (UDVA)
timeFrame: Three months after intraocular lens implantation
measure: Monocular visual acuity for intermediate vision with correction for distance (DCIVA)
timeFrame: Three months after intraocular lens implantation
measure: Monocular visual acuity for intermediate vision without correction (UIVA)
timeFrame: Three months after intraocular lens implantation
measure: Monocular visual acuity for near vision with correction for distance (DCNVA)
timeFrame: Three months after intraocular lens implantation
measure: Monocular visual acuity for near vision without correction (UNVA)
timeFrame: Three months after intraocular lens implantation
measure: Postoperative refractive error
timeFrame: Three months after intraocular lens implantation
measure: Monocular Contrast sensitivity
timeFrame: Three months after intraocular lens implantation
measure: Binocular Contrast sensitivity
timeFrame: Three months after intraocular lens implantation
measure: Defocus curve
timeFrame: Three months after intraocular lens implantation
measure: CATQuest 9SF
timeFrame: Three months after surgery
measure: Visual Symptoms questionnaire
timeFrame: Three months after surgery
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital La Arruzafa
state: Cordoba
Study officials:
affiliation: Hospital La Arruzafa
name: Antonio Cano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: