The Best Way to Improve the Near Visual Acuity After ZXR00 IOL Implantation

Study Overview
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Brief Summary
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The Best Way to Improve the Near Visual Acuity After ZXR00 IOL Implantation

Detailed Description
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ZXR00 intraocular lens is a new type of IOL that can achieve good continuous visual acuity. Its characteristic is to improve the distance and intermedia visual acuity and maintain good visual quality while sacrificing the near visual acuity. Previous studies report that there are mainly two ways to improve the near visual acuity of ZXR00：1.Bilateral implantation of ZXR00 with micromonovision. 2. Combined Implantation of ZXR00 and multifocal IOLs.This study aim to explore which is the best way to improve the near visual acuity after ZXR00 IOL implantation.

Official Title
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The Best Way to Improve the Near Visual Acuity After Implantation of Tecnis Symfony® ZXR00 Intraocular Lens

Conditions
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Cataract, Near Vision

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18-80 years Cataract surgery is planned The operation was successful without any complications Implanted with ZXR00 IOLS or ZMB00 IOLs Exclusion Criteria: The history of retinopathy or retinal surgery Irregular corneal astigmatism Regular corneal astigmatism of 1.00 diopter (D) or more Iris abnormalities Macular degeneration Neuro-ophthalmic disease The history of ocular inflammation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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+ZXR00 emmetropia group<br>The bilateral implantation of ZXR00 IOLs，and emmetropia was considered as the target refraction for both eyes. | |
| ZXR00+ZXR00 micromonovision group<br>The bilateral implantation of ZXR00 IOLs，and the ZXR00 IOLs power calculations were performed using a micro-monovision approach aiming for minimal residual myopia (≈ -0.50 D) in the nondominant eye and emmetropia in the dominant eye. | |
| ZXR00ZMB00 group<br>The blended implantation of bifocal IOLs (ZMB00) and ZXR IOLs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Visual Acuities | Uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm). | 2022.12.31 | 
| Corrected Visual Acuities | Corrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm). | 2022.12.31 | 
| Defocus Curve | Corrected monocular and binocular defocus curves were measured from +2.5 D to -4.0 D (in 0.5 D steps). | 2022.12.31 | 
| Patient satisfaction | Patient satisfaction was rated on a scale of 1 to 5: 1 = very dissatisfied; 2 = dissatisfied; 3 = neutral; 4 = satisfied; and 5 = very satisfied. | 2022.12.31 | 
| Subjective quality of vision | Subjective quality of vision was evaluated using the 14-item Visual Function Questionnaire (VFQ-14).Each item was scaled according to the degree of difficulty of different activities: 4 points (no difficulty), 3 points (a little difficulty), 2 points (a moderate amount of difficulty), 1 point (a great deal of difficulty), and 0 point (unable to do the activity).overall score is range 0-56.The higher the score, the worse subjective quality of vision. | 2022.12.31 | 
| Adverse visual symptoms | Adverse visual symptoms including blurred vision, glare, starbursts, haloes, hazy vision, distortion, focusing diffculties, multiple images, and depth perception diffculty, was evaluated using the Quality of Vision test. This test includes 30 items, with a score between 0 and 3 (overall score range 0-90).The higher the score, the more postoperative adverse visual symptoms. | 2022.12.31 | 
| Stereopsis | Stereopsis was evaluated using OCULUS Binoptometer. | 2022.12.31 |