Evaluation of Visual Acuity in Myopic Cataract Patients Using Trifocal Intraocular Lens

Study Overview
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Brief Summary
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The PanOptix trifocal IOL is a new trifocal intraocular lens which is proved to provide good range of vision for distance, intermediate and near and good visual quality in cataract patients with normal axial length. But whether it can get the same visual quality in myopia is still unknown

Detailed Description
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There are a few publications of multi-focal IOLs on Chinese patients with high myopia. From published papers, it is known that performance of multifocal IOLs is satisfied in myopic patients. However there is no publication to investigate PanOptix in moderate and high myopic patients. So it is imperative to demonstrate good performance of PanOptix in those special patients. The purpose of this study is to assess visual performance and patient satisfaction after the implantation of PanOptix in myopic patients.

Official Title
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Evaluation of Binocular Visual Acuity in Myopic Cataract Patients Using Trifocal Intraocular Lens : a 2 Years Prospective, Observational, Multi-center Study

Conditions
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Intraocular Lens, Cataract, Myopia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Axial myopic patients（Refractive condition match the axial length after eliminate the nuclear cataract induced myopia factor） Corneal astigmatism <1.0D (IOL-Master 500/700, Carl Zeiss Meditec, Jena, Germany); Eyes with pupil diameter>2.5 mm (Photopic) and<6 mm (Mesopic) (Pentacam HR, Oculus Optikgerate GmbH); Eyes with angle kappa<0.50 mm (Pentacam HR); Eyes with corneal spherical aberration<0.50 (Pentacam HR) Exclusion Criteria: Irregular corneal astigmatism Any retinal disease, macular disease(Including myopic MD and retinal diseases) could affect VA, glaucoma and other severe intraocular diseases Moderate-severe dry eye Amblyopia（BCDVA<0.7 before cataract appears） Patients having difficulties with examinations or 3 months' follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| high myopic group (group1:AL≥26.0 mm)<br>axial length≥26.0 mm) | |
| age-matched control group<br>axial length<26.0mm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length (AL) | Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany) | 1 minute | 
| Uncorrected distance visual acuity | Uncorrected distance visual acuity (4m) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA). | 10 minutes | 
| Uncorrected near visual acuity | Uncorrected near visual acuity (40cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA). | 10 minutes | 
| Uncorrected intermediate visual acuity | Uncorrected intermediate visual acuity (60cm) were measured using the reading table model of the Early Treatment Diabetic Retinopathy Study charts (ETDRS; Vector Vision, Ltd, Greenville, OH, USA) | 10 minutes | 
| contrast sensitivity | Binocular contrast sensitivity was measured at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the functional acuity contrast test(Test SV-1000) of the CC-100 HW 5.0 Series system | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, visual acuity, monocular defocus curve, binocular contrast sensitivity