Myopic Optic Neuropathy in Chinese High Myopia Population

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04302220

Enrollment

813

Registered

2020-03-10

Start date

2019-06-06

Completion date

2026-06-30

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Diseases

Keywords

myopic optic neuropathy, high myopia, glaucoma

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Progression of glaucoma within 36 months	3 years	Structural and functional changes of glaucoma using visual field, stereoscopic fundus photography.

Secondary

Measure	Time frame	Description
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.

Countries

China

Outcome results