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

NCT ID: NCT05594537

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract Near Vision

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ZXR00+ZXR00 emmetropia group

The bilateral implantation of ZXR00 IOLs,and emmetropia was considered as the target refraction for both eyes.

No interventions assigned to this group

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.

No interventions assigned to this group

ZXR00ZMB00 group

The blended implantation of bifocal IOLs (ZMB00) and ZXR IOLs.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yune Zhao

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yune Zhao

Role: STUDY_DIRECTOR

Ophthalmology and Optometry Hospital

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yune Zhao

Role: CONTACT

8613819707056

Jiayan Fang

Role: CONTACT

8615957793328

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZXR00-zyy

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.