Clinical Results of Asqelio™ EDOF Toric Soft Hydrophobic Intraocular Lens After Cataract Surgery

N/AUnknownNCT06229756

AST Products, Inc.30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

30

Conditions

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

NCT06229756 - Clinical Results of Asqelio™ EDOF Toric Soft Hydrophobic Intraocular Lens After Cataract Surgery | Crick | Crick

Outcomes

Primary Outcomes

Uncorrected Monocular Visual acuity for distance

Visual acuity without additional correction determined at a distance of 4 m in LogMAR units

Time frame: 3 months after implantation

Uncorrected Monocular Visual acuity for intermediate distance

Visual acuity without additional correction determined at a distance of 67 cm in LogMAR units

Time frame: 3 months after implantation

Uncorrected Monocular Visual acuity for near distance

Visual acuity without additional correction determined at a distance of 40 cm in LogMAR units

Time frame: 3 months after implantation

Corrected Monocular Visual acuity for distance

Visual acuity with best correction determined at a distance of 4 m in LogMAR units

Time frame: 3 months after implantation

Corrected Monocular Visual acuity for intermediate distance

Visual acuity with best correction determined at a distance of 67 cm in LogMAR units

Time frame: 3 months after implantation

Corrected Monocular Visual acuity for near distance

Visual acuity with best correction determined at a distance of 40 cm in LogMAR units

Time frame: 3 months after implantation

Refractive error

Residual refractive error after implantation obtained by subjective refraction methods

Time frame: 3 months after implantation

Secondary Outcomes

Contrast sensitivity function under photopic conditions

Contrast sensitivity measured under photopic conditions for spatial frequencies of 3, 6, 12 and 18 cycles per degree using the Clinical Trial Suite in logCS units

Time frame: 3 months after implantation

Contrast sensitivity function under mesopic conditions

Contrast sensitivity measured under mesopic conditions for spatial frequencies of 1.5, 3, 6 and 12 cycles per degree using the Clinical Trial Suite in logCS units

Time frame: 3 months after implantation

Contrast sensitivity function under photopic conditions with glare

Contrast sensitivity measured under photopic conditions inducing glare, for spatial frequencies of 3, 6, 12 and 18 cycles per degree using the Clinical Trial Suite in logCS units

Time frame: 3 months after implantation

Contrast sensitivity function under mesopic conditions with glare

Contrast sensitivity measured under mesopic conditions inducing glare, for spatial frequencies of 1.5, 3, 6 and 12 cycles per degree using the Clinical Trial Suite in logCS units

Time frame: 3 months after implantation

Binocular defocus curve

Visual acuity in logMAR units under binocular conditions, determined varying the stimulus mergence using lenses from -4.00D to +2.00D in 0.50D steps and best refractive correction for distance

Time frame: 3 months after implantation

Aberrometry

Optical quality measured as Zernike coefficients for total Root Mean Square of Higher order aberrations, and Spherical aberrations, expressed in microns

Time frame: 3 months after implantation

Light distortion

Distortion of light as light distortion index, determined by means of the light distortion analyzer

Time frame: 3 months after implantation

Patient-reported visual symptoms

Incidence and severity of visual symptoms, determined by means of a visual symptoms questionnaire. Incidence will be scored in a scale from 1 (never) to 4 (always), severity from 1 (none) to 4 (severe), and bothersome rom 1(none) to 4 (a lot)

Time frame: 3 months after implantation

Patient-reported satisfaction

Level of satisfaction with vision and difficulty performing daily activities, determined by means of the CATQuest 9SF questionnaire, where items are scored in a scale from 1 (yes, a lot of difficulties) to 4 (no, no difficulties) and a "cannot decide" option. Satisfaction is scored from 1 (very unsatisfied) 4 (very satisfied) and a "cannot decide" option

Time frame: 3 months after surgery

Incidence of Adverse events

Percentage of patients presenting adverse events (ocular and non ocular, severe and not severe), including secondary surgical procedures

Time frame: 3 months after surgery