Clinical trial NCT06229756: Clinical Results of Asqelio™ EDOF Toric Soft Hydrophobic Intraocular Lens After Cataract Surgery
Official title: Clinical Results of Asqelio™ EDOF Toric Soft Hydrophobic Intraocular Lens After Cataract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Lead sponsor: AST Products, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects submitted to bilateral cataract surgery with implantation of extended depth of focus IOLs according to common clinical practice

Brief summary: 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:

* What is the visual performance at different distances 3 months after implantation of Asqelio EDOF Toric in both eyes?
* What is the amount of residual refractive error following the implantation?
* What is the contrast sensitivity of patients 3 months after implantation of Asqelio EDOF Toric in both eyes?
* What is the optical quality of the eye implanted with Asqelio EDOF Toric IOL?
* What is the incidence and severity of visual symptoms after implantation of Asqelio EDOF Toric?
* What is the level of patient satisfaction after implantation of Asqelio EDOF Toric?

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.


Eligibility criteria: Inclusion Criteria:

* Patients 50 years old or more submitted to bilateral cataract surgery and implanted with Asqelio EDOF toric IOL, with cylinder value of 0.0 D.
* Patients signing informed consent
* Transparent media except for the cataracts
* Potential postoperatoria 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
* Microphtalmos
* Severe corneal dystrophy
* Uncontrolled or medically controlled glaucoma
* Clinically significant macular changes
* Concomitant severe eye disease
* Non-age-related cataract
* Severe optic nerve atrophy
* Diabetic retinopathy
* Proliferative diabetic retinopathy
* Amblyopia
* Extremely shallow anterior camera
* Severe chronic uveítis
* Pregnant or nursing
* Rubella
* Mature/dense cataract that makes it difficult to examine the fundus preoperatively.
* Previous retinal detachment
* Concurrent participation in other research with drugs or clinical devices
* Expect to require another eye surgery during the study period

Primary outcomes:
measure: Uncorrected Monocular Visual acuity for distance
timeFrame: 3 months after implantation
measure: Uncorrected Monocular Visual acuity for intermediate distance
timeFrame: 3 months after implantation
measure: Uncorrected Monocular Visual acuity for near distance
timeFrame: 3 months after implantation
measure: Corrected Monocular Visual acuity for distance
timeFrame: 3 months after implantation
measure: Corrected Monocular Visual acuity for intermediate distance
timeFrame: 3 months after implantation
measure: Corrected Monocular Visual acuity for near distance
timeFrame: 3 months after implantation
measure: Refractive error
timeFrame: 3 months after implantation
Secondary outcomes:
measure: Contrast sensitivity function under photopic conditions
timeFrame: 3 months after implantation
measure: Contrast sensitivity function under mesopic conditions
timeFrame: 3 months after implantation
measure: Contrast sensitivity function under photopic conditions with glare
timeFrame: 3 months after implantation
measure: Contrast sensitivity function under mesopic conditions with glare
timeFrame: 3 months after implantation
measure: Binocular defocus curve
timeFrame: 3 months after implantation
measure: Aberrometry
timeFrame: 3 months after implantation
measure: Light distortion
timeFrame: 3 months after implantation
measure: Patient-reported visual symptoms
timeFrame: 3 months after implantation
measure: Patient-reported satisfaction
timeFrame: 3 months after surgery
measure: Incidence of Adverse events
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: OftalVist Alicante
Study officials:
References: