Clinical trial NCT04302220: Myopic Optic Neuropathy in Chinese High Myopia Population
Official title: Natural History of Myopic Optic Neuropathy for High Myopia in Chinese Adult Population: a Registry Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Eye Diseases
Keywords: myopic optic neuropathy
high myopia
glaucoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 813
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have high myopia aged from 18 to above.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression of glaucoma within 36 months
timeFrame: 3 years
Secondary outcomes:
measure: Progression of myopia and other structural changes of retina and choroid.
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiulan Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin F, Chen S, Song Y, Li F, Wang W, Zhao Z, Gao X, Wang P, Jin L, Liu Y, Chen M, Liang X, Yang B, Ning G, Cheng CY, Healey PR, Park KH, Zangwill LM, Aung T, Ohno-Matsui K, Jonas JB, Weinreb RN, Zhang X; Glaucoma Suspects with High Myopia Study Group. Classification of Visual Field Abnormalities in Highly Myopic Eyes without Pathologic Change. Ophthalmology. 2022 Jul;129(7):803-812. doi: 10.1016/j.ophtha.2022.03.001. Epub 2022 Mar 12.
citation: Song Y, Wang W, Lin F, Chen S, Jin L, Li F, Gao K, Cheng W, Xiong J, Zhou R, Chen M, Liang J, Zhang J, Jonas JB, Zhang X. Natural history of glaucomatous optic neuropathy in highly myopic Chinese: study protocol for a registry cohort study. BMJ Open. 2020 Dec 30;10(12):e039183. doi: 10.1136/bmjopen-2020-039183.