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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract; Near Vision

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Jiayan Fang; Phone Number: 8615957793328; Email: 1132093186@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From December 2019 to present, cataract patients underwent phacoemulsification combined with ZXR00 IOLs or ZMB00 IOLs implantation by an experienced ophthalmologist (Dr. Zhao Yune) in Wenzhou Medical University Affiliated Eye Hospital(hangzhou branch).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
ZXR00+ZXR00 emmetropia group; The bilateral implantation of ZXR00 IOLs，and emmetropia was considered as the target refraction for both eyes.
ZXR00+ZXR00 micromonovision group; 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; The blended implantation of bifocal IOLs (ZMB00) and ZXR IOLs.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yune Zhao

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Myopia
• Other Study ID Numbers: ZXR00-zyy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No