Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens

Study Overview
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Brief Summary
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The study aims to evaluate the clinical outcomes six months after implantation of the trifocal diffractive intraocular lens Asqelio Trifocal IOL TFLIO130C in healthy subjects submitted to non-traumatic cataract surgery. This clinical performance will be assessed in terms of refractive error, visual performance at different distances, incidence of adverse events and complications following implantation, and patient satisfaction.

Official Title
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Clinical Results of Asqelio Trifocal Diffractive Intraocular Lens

Conditions
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Cataract

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients submitted to cataract surgery and implanted with Asqelio Trifocal IOL TFLIO130C Patients signing a consent form Patients seeking spectacle-independence following surgery IOL power between +5.00 and +34.00 D Transparent intraocular media, except for the cataract prior to surgery, in both eyes Postoperatory potential visual acuity of 20/25 or better. Exclusion Criteria: Preoperatory corneal astigmatism greater than 0.75D Patients not providing informed consent Previous corneal surgery or trauma Irregular cornea (i.e. keratoconus) Choroidal hemorrhage Microophthalmos Severe corneal dystrophy Uncontrolled or medically controlled glaucoma Clinically significant macular changes Severe concomitant ocular disease Not age-related cataract Severe optic nerve atrophy Diabetic retinopathy Ambyopia Extremely shallow anterior chamber Severe chronic uveitis Pregnant or lactating Rubella Mature/Dense cataract sifficulting preoperative fundus assessment Previous retinal detachment Concurrent participation in other investigation using drugs or clinical devices Expecting ocular surgery within the study period

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Percentage of subjects with adverse events (Ocular and Not Ocular, Severe and Not Severe), including secondary surgical procedures | Six months after implantation | 
| Refraction | Manifest refraction both monocular and binocularly using subjective methods | Six months after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected visual acuity for distance (4m) | Monocular visual acuity for distance (4m), without any additional correction, using ETDRS vision chart | Six months after implantation | 
| Best-corrected visual acuity for distance (4m) | Monocular visual acuity for distance (4m), with the best correction for distance, using ETDRS vision chart | Six months after implantation | 
| Uncorrected visual acuity for intermediate | Monocular visual acuity for intermediate distance (60cm), without any additional correction, using ETDRS vision chart | Six months after implantation | 
| Best-corrected visual acuity for intermediate | Monocular visual acuity for intermediate distance (60cm), with the best correction for distance, using ETDRS vision chart | Six months after implantation | 
| Uncorrected visual acuity for near | Monocular visual acuity for near distance (40cm), without any additional correction, using ETDRS vision chart | Six months after implantation | 
| Best-corrected visual acuity for near | Monocular visual acuity for near distance (40cm), with the best correction for distance, using ETDRS vision chart | Six months after implantation | 
| Contrast sensitivity function (CSF) | CSF with best correction, with and without induced glare, using the Clinical Trial Suite | Six months after implantation | 
| Defocus curve | Defocus curve of visual performance varying the stimulus vergence from -4.0 D to +1.0 D in 0.5 D steps with the best correction for distance | Six months after implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract surgery, intraocular lens, multifocal refractive correction