Myopic Optic Neuropathy in Chinese High Myopia Population

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04302220
Collaborator
(none)
813
1
48.8
16.7

Study Details

Study Description

Brief Summary

This study intends to establish a registry cohort to enroll patients with high myopia to study the natural course of myopic optic neuropathy in Chinese adult population.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Global prevalence of high myopia brings about markedly increasing of blinding complications as myopic optic neuropathy (MON) and glaucoma. It was estimated that there were 163 million people who have high myopia in 2000, and the population with high myopia would increase to almost one billion (9.8% of the world population) worldwide by 2050.

    Glaucoma is the leading cause of irreversible blindness worldwide while it is difficult to distinguish glaucoma among MON in high myopia eyes. However, there lack longitudinal study to illustrate the natural course interpreting the distribution and natural history of MON.

    In view of the above problems, this is a longitudinal registry cohort study to observe the long-term changes of structural and functional parameters of MON in high myopia, and to investigate the natural course and associted risk factors that influence the progression in a Chinese adult population.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    813 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Natural History of Myopic Optic Neuropathy for High Myopia in Chinese Adult Population: a Registry Cohort Study
    Actual Study Start Date :
    Jun 6, 2019
    Anticipated Primary Completion Date :
    Mar 31, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    high myopia

    Population who have high myopia.

    Outcome Measures

    Primary Outcome Measures

    1. Progression of glaucoma within 36 months [3 years]

      Structural and functional changes of glaucoma using visual field, stereoscopic fundus photography.

    Secondary Outcome Measures

    1. Progression of myopia and other structural changes of retina and choroid. [3 years]

      Structural and functional changes of myopia based on axial length and refractive error.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Inclusion Criteria

    • Age ≥18 years

    • Equivalent spherical ≤-6D or axial length ≥26.5mm

    • Best corrected visual acuity ≥ 6/12

    Exclusion Criteria

    • Unwilling or unable to give consent, or unable to return for scheduled protocol visits.

    • Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery, or neovascular disease.

    • Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, VF test or monophthalmia.

    • Need for ocular surgery/laser or anticipated need for cataract surgery during the study period.

    • Other serious systemic diseasesf (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases);

    • Pregnant or nursing women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Ophthalmic Center Guangzhou Guangdong China 510000

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Xiulan Zhang, MD, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiulan Zhang, Professor of Ophthalmology, Director of Clinical Research Center, Director of CFDA-certified Pharmaceutical Research Unit, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT04302220
    Other Study ID Numbers:
    • 2019KYPJ079
    First Posted:
    Mar 10, 2020
    Last Update Posted:
    May 6, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Keywords provided by Xiulan Zhang, Professor of Ophthalmology, Director of Clinical Research Center, Director of CFDA-certified Pharmaceutical Research Unit, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2022