Visual Performance of Multifocal Intraocular Lenses

Study Overview
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Brief Summary
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To evaluate the clinical outcomes with an extended range of vision (ERV) IOL based on achromatic diffractive technology.

Detailed Description
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This was a prospective comparative study including 60 eyes undergoing cataract surgery with implantation of the ERV Tecnis Symfony IOL (Abbott Medical Optics, Inc.) (ERV group: 60 eyes of 30 patients). Visual, refractive, contrast sensitivity, defocus curve, ocular optical quality (Optical Quality Analysis System; iTrace), and visual function questionair（NEI-VFQ 25） outcomes were evaluated during a 3-month follow-up.

Official Title
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Clinical Outcomes With an Extended Range of Vision Intraocular Lens

Conditions
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IOL, Cataract

Intervention / Treatment
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* Device: ZXR00


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: visually significant cataract age of 20 years or older preoperative corneal astigmatism of 1.50 diopters (D) or lower. Exclusion Criteria: previous ocular surgery active ocular pathology amblyopia systemic or ocular medication that could affect vision subclinical or clinical corneal ectatic disease pupil abnormalities intraoperative complication leading to capsular or zonular abnormalities

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| ZXR00<br>The ZXR00 group included 30 patients bilaterally implanted with the Tecnis Symfony IOL (Abbott Medical Optics, Inc.) | Device: ZXR00<br>* This prospective comparative study included 60 eyes undergoing cataract surgery with implantation of an extended range of vision IOL.(Abbott Medical Optics, Inc.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected distance VA（5m，66cm，40cm） | logarithmic visual acuity chart | After operation （Month 3） | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire concerning halo and visual function | NEI-VFQ 25 patient questionnaire score. The questionnaire consisted of 3 parts. The first part assessed patients' satisfaction with their overall vision during the day, or at night. The score ranged from 1 to 5 (1 = not at all; 2 = a little bit; 3 = moderately; 4 = quite a bit; 5 = extremely). In part 2, patients were asked to rate the extent to which they have difficulties with their overall vision during the day or at night. The score ranged from 1 to 5 (1 = none of the time; 2 = some of the time; 3 = half of the time; 4 = most of the time; 5 = all of the time). In part 3, patients were asked to rate their overall vision and their vision at near, intermediate, and distance on a scale ranging from 0 to 10 (0 = worst; 10 = best). | After operation （Month 3） | 
| abberation and kappa angle | iTrace visual function analyzer | After operation （Month 3） | 
| MTF cut-of and OSI | MTF cut-of and OSI values measured by optical quality analysis system [OQAS] | After operation （Month 3） | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multifocal IOL, ocular optical quality, abberation