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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05594537
• Other study ID #: ZXR00-zyy
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: October 2022
• Source: Wenzhou Medical University
• Contact: Yune Zhao
• Phone: 8613819707056
• Email: zyehzeye[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Myopia
• Near Vision

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yune Zhao

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Stereopsis	Stereopsis was evaluated using OCULUS Binoptometer.	2022.12.31