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NCT Number: NCT04302220

Myopic Optic Neuropathy in Chinese High Myopia Population

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression of glaucoma within 36 months

    Time frame: 3 years

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

Secondary outcomes

  1. Progression of myopia and other structural changes of retina and choroid.

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Natural History of Myopic Optic Neuropathy for High Myopia in Chinese Adult Population: a Registry Cohort Study

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2020
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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