NCT05594537

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

October 20, 2022

Last Update Submit

October 25, 2022

Conditions

CataractNear Vision

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Age of 18-80 years
  • Cataract surgery is planned
  • The operation was successful without any complications
  • Implanted with ZXR00 IOLS or ZMB00 IOLs

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CataractMyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Yune Zhao

    Ophthalmology and Optometry Hospital

    STUDY DIRECTOR

Central Study Contacts

Yune Zhao

CONTACT

8613819707056zyehzeye@126.com

Jiayan Fang

CONTACT

86159577933281132093186@qq.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 26, 2022

Study Start

November 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 31, 2023

Last Updated

October 26, 2022

Record last verified: 2022-10