Myopic Optic Neuropathy in Chinese High Myopia Population

Eye Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04302220
• Other study ID #: 2019KYPJ079
• Status: Recruiting
• Start date: June 6, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2022
• Source: Sun Yat-sen University
• Contact: Xiulan Zhang, MD, PhD
• Phone: +86 13570166308
• Email: zhangxl2[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 813
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Myopia
• Optic Nerve Diseases

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of glaucoma within 36 months	Structural and functional changes of glaucoma using visual field, stereoscopic fundus photography.	3 years
Secondary	Progression of myopia and other structural changes of retina and choroid.	Structural and functional changes of myopia based on axial length and refractive error.	3 years