Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens

Study Overview
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Brief Summary
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The main objective of this study was to evaluate distance, intermediate, and near vision in patients who have undergone cataract extraction with bilateral implantation of a new hydrophobic trifocal diffractive intraocular lens (IOL) with a biospheric design, the Asqelio Trifocal IOL (AST Products, Inc., Billerica MA, USA), along with patient-reported outcomes (PRO). For that purpose the clinical information of 50 eyes from 25 patients was retrospectively analyzed 3 months after implantation

Official Title
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Retrospective Study on the Clinical Behavior of the Asqelio™ Trifocal Diffractive Intraocular Lens With Follow-up at 3 Months

Conditions
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Cataract

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 years or older submitted to cataract surgery with binocular implantation of Asqelio Trifocal TFLIO130C IOL Seeking spectacle independence after surgery IOL power between +5.0D y +34.0D Transparent ocular media, except for the cataract prior to surgery. Potential postoperatory visual acuity of 20/25 or better, as assessed prior to surgery Exclusion Criteria: Preoperatory corneal astigmatism greater than 1.0D Previous corneal surgery or trauma Irregular cornea (e.g. keratoconus) Choroidal hemorrhage Microftalmos Severe corneal dystrophy Uncontrolled or medically controlled glaucoma Clinically significant macular changes Severe concomitant ocular condition Cataract not age-related Severe optic nerve atrophy Diabetic retinopathy Ambyopia Extremely shallow anterior chamber Severe chronic uveitis Pregnancy or lactating Rubella Mature/dense cataract difficulting preoperatory eye fundus assessment Previous retinal detachment Concurrent participation in another investigation involving drugs or medical devices

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- | --- |
| Uncorrected distance visual acuity | Uncorrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units | 3 months after implantation | 
| Best-corrected distance visual acuity | Best-corrected visual acuity for distance (4m) determined under photopic conditions using EDTRS optotypes, in LogMAR units | 3 months after implantation | 
| Uncorrected intermediate visual acuity | Uncorrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units | 3 months after implantation | 
| Distance-corrected intermediate visual acuity | Distance-corrected visual acuity for intermediate disntace (60cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units | 3 months after implantation | 
| Uncorrected near visual acuity | Uncorrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units | 3 months after implantation | 
| Distance-corrected near visual acuity | Distance-corrected visual acuity for near (40cm) determined under photopic conditions using EDTRS optotypes, in LogMAR units | 3 months after implantation | 
| Defocus curve | Binocular defocus curve with best correction for distance obtained varying mergence from -4.0D to +2.0D in 0.5D steps | 3 months after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manifest Refraction | Refraction determined monocularly by subjective refraction methods, in diopters | Preoperatively and 3 months after implantation | 
| Adverse events | Percentage of subjects with adverse events (ocular and non ocular, severe and non severe), including secondary surgical interventions | 3 months after implantation | 
| Patient-reported outcomes CATQuest9SF | Patient reported outcomes were assessed by CATQuest9SF questionnaire | 3 months after implantation | 
| Patient-reported outcomes PRSIQ | Patient reported outcomes were assessed by patient-reported spectacle independence questionnaire (PRSIQ) | 3 months after implantation | 
| Patient-reported outcomes PRVSQ | Patient reported outcomes were assessed by the patient-reported visual symptoms questionnaire (PRVSQ) | 3 months after implantation |