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

Sponsor
Yune Zhao (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05594537
Collaborator
(none)
30
3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Best Way to Improve the Near Visual Acuity After Implantation of Tecnis Symfony® ZXR00 Intraocular Lens
    Anticipated Study Start Date :
    Nov 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Jan 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Uncorrected Visual Acuities [2022.12.31]

      Uncorrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm).

    2. Corrected Visual Acuities [2022.12.31]

      Corrected monocular and binocular visual acuities (logarithm of the minimum angle of resolution) at distance (5m), intermediate(66 cm), and near (40 cm).

    3. Defocus Curve [2022.12.31]

      Corrected monocular and binocular defocus curves were measured from +2.5 D to -4.0 D (in 0.5 D steps).

    4. Patient satisfaction [2022.12.31]

      Patient satisfaction was rated on a scale of 1 to 5: 1 = very dissatisfied; 2 = dissatisfied; 3 = neutral; 4 = satisfied; and 5 = very satisfied.

    5. Subjective quality of vision [2022.12.31]

      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.

    6. Adverse visual symptoms [2022.12.31]

      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.

    7. Stereopsis [2022.12.31]

      Stereopsis was evaluated using OCULUS Binoptometer.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Yune Zhao

    Investigators

    • Study Director: Yune Zhao, Ophthalmology and Optometry Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT05594537
    Other Study ID Numbers:
    • ZXR00-zyy
    First Posted:
    Oct 26, 2022
    Last Update Posted:
    Oct 26, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 26, 2022