Myopic Optic Neuropathy in Chinese High Myopia Population

NCT04302220 | Active Not Recruiting DMC

• 1 other identifier: 2019KYPJ079
• Study Type: observational
• Target: 813
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Diseases

Keywords

myopic optic neuropathy; high myopia; glaucoma

Outcome Measures

Primary Outcomes (1)

• Progression of glaucoma within 36 months

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

  3 years

Secondary Outcomes (1)

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

  3 years

Study Arms (1)

high myopia

Population who have high myopia.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have high myopia aged from 18 to above.

You may qualify if:

• Age ≥18 years
• Equivalent spherical ≤-6D or axial length ≥26.5mm
• Best corrected visual acuity ≥ 6/12

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (2)

• 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.

  PMID: 35288144 DERIVED

• 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.

  PMID: 33380478 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva smple.

MeSH Terms

Conditions

Eye Diseases; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension

Study Officials

• Xiulan Zhang, MD, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology, Director of Clinical Research Center, Director of CFDA-certified Pharmaceutical Research Unit, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: March 7, 2020
• First Posted: March 10, 2020
• Study Start: June 6, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

CN (1)