Effect of Peripapillary Atrophy to Diagnose Glaucoma in High Myopia

Myopia Clinical Trial

Official title:

Effect of Peripapillary Atrophy Based on Optical Coherence Tomography to Diagnose Primary Open Angle Glaucoma in High Myopia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05964634
• Other study ID #: 2023KYPJ105
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: July 2023
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Yiqing Li
• Phone: +86 13302235127
• Email: liyiqing[@]gzzoc.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study intends to analyze the characteristics between peripapillary retinal nerve fiber layer thickness and peripapillary area in high myopia with or without glaucoma

Description:

Glaucoma is the leading cause of irreversible blindness in the world. Myopia is a risk factor for glaucoma. With the rising prevalence of both myopia and glaucoma in an ageing population, the occurrence of these two ocular conditions in the same patient is likely to increase. 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.

There is often a diagnostic challenge to the clinician, since the detection of glaucomatous optic nerve damage in highly myopic eyes is difficult. Recently, the subclassification of peripapillary area could potentially be used to differentiate myopic eyes with and without glaucoma according to OCT findings.

However, the characteristics of peripapillary atrophy have not been fully applied in the diagnosis of high myopia and glaucoma.

In view of the above problems, the purpose of this study is to analyze the peripapillary area based on optical coherence tomography and it may be a specific marker for identifying high myopia with primary open angle glaucoma.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 31, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years.

2. Equivalent spherical =-6D or axial length =26.5mm.

3. High myopia with primary open angle glaucoma, such as anterior chamber angle is opening, optic rim defect, RNFL loss, etc.

4. The peripapillary region can be accurately defined Based on OCT.

Exclusion Criteria:

(1) Exclusion criteria for high myopia group:

1. History of glaucoma and elevated intraocular pressure.

2. History of uveitis or intraocular surgery.

3. History of other retinal optic nerve or related systemic diseases.

4. The examination results are unreliable, such as poor image quality.

(2) Exclusion criteria for high myopia with primary open angle glaucoma group:

1. Others nervous system diseases, such as visual field loss or optic nerve damage.

2. Others non-glaucomatous ocular pathologies may affect the visual field or retinal nerve fiber layer status, such as retinal diseases, uveitis, or ocular surgery history.

Related Conditions & MeSH terms

• Atrophy
• Eye Diseases
• Glaucoma
• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle
• Myopia
• Refractive Errors

Intervention

Diagnostic Test:
• OCT imaging
Image J or Spectralis OCT built-in software package was used to manually locate and measure the area and width of the temporal parapapillary atrophy.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

Dai Y, Jonas JB, Huang H, Wang M, Sun X. Microstructure of parapapillary atrophy: beta zone and gamma zone. Invest Ophthalmol Vis Sci. 2013 Mar 19;54(3):2013-8. doi: 10.1167/iovs.12-11255. — View Citation

Wang YX, Panda-Jonas S, Jonas JB. Optic nerve head anatomy in myopia and glaucoma, including parapapillary zones alpha, beta, gamma and delta: Histology and clinical features. Prog Retin Eye Res. 2021 Jul;83:100933. doi: 10.1016/j.preteyeres.2020.100933. Epub 2020 Dec 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of circumpapillary retinal nerve fiber layer thickness changes within 12 months	The circle with a diameter of 3.46 mm is scanned by Spectralis OCT instrument with the optic disc as the center and the RNFL thickness was calculated by built-in software.	1 years
Primary	Evaluation of the area of the peripapillary area changes within 12 months	The results of Spectralis OCT instrument are exported, and used Image J or Spectralis OCT built-in software package to manually locate and measure the area of the temporal parapapillary area	1 year
Primary	Evaluation of the width of the peripapillary area changes within 12 months	The results of Spectralis OCT instrument are exported, and used Image J or Spectralis OCT built-in software package to manually locate and measure the width of the temporal parapapillary area	1 year
Secondary	Demographic characteristics	Including but not limited to gender, age, duration of illness	1 day of enrollment
Secondary	blood pressure	Demographic characteristics	1 day of enrollment
Secondary	BMI	weight (lb) / [height (in)]2	1 day of enrollment
Secondary	Best corrected visual acuity	Best corrected visual acuity after refractive error correction using the ETDRS chart	1 day of enrollment
Secondary	Evaluation of the intraocular pressure changes within 12 mouths	IOP is measured by goldmann tonometer.	1 year
Secondary	Evaluation of the visual field changes within 12 mouths	Assess the degree of visual function damage	1 year
Secondary	Axial length	axial length is measured using A-type ultrasound.	1 day of enrollment
Secondary	Evaluation of the fundus changes within 12 months	Fundus photography uses kowa fundus camera	1 year
Secondary	Ocular anterior segment structure	The ocular anterior segment structure uses lit-lamp biomicroscope	1 day of enrollment

External Links

•   beta zone and gamma zone defined based on OCT
•   Microstructure of parapapillary atrophy