Effect of Peripapillary Atrophy to Diagnose Glaucoma in High Myopia

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Eye Diseases; Refractive Errors; Myopia; Glaucoma, Primary Open Angle; Peripapillary Atrophy
• Intervention / Treatment: Diagnostic test: OCT imaging

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Yiqing Li; Phone Number: +86 13302235127; Email: liyiqing@gzzoc.com
• Study Contact Backup: Name: Jinpeng Yang; Phone Number: +86 18595813993; Email: yangjp35@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who have high myopia with or without glaucoma.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
myopic glaucoma; Patiens who have high myopia with primary open angle glaucoma	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.
healthy myopia; Patiens who have high myopia without primary open angle glaucoma	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristics	Including but not limited to gender, age, duration of illness	1 day of enrollment
blood pressure	Demographic characteristics	1 day of enrollment
BMI	weight (lb) / [height (in)]2	1 day of enrollment
Best corrected visual acuity	Best corrected visual acuity after refractive error correction using the ETDRS chart	1 day of enrollment
Evaluation of the intraocular pressure changes within 12 mouths	IOP is measured by goldmann tonometer.	1 year
Evaluation of the visual field changes within 12 mouths	Assess the degree of visual function damage	1 year
Axial length	axial length is measured using A-type ultrasound.	1 day of enrollment
Evaluation of the fundus changes within 12 months	Fundus photography uses kowa fundus camera	1 year
Ocular anterior segment structure	The ocular anterior segment structure uses lit-lamp biomicroscope	1 day of enrollment

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; glaucoma; high myopia; Peripapillary Atrophy
• Additional Relevant MeSH Terms: Ocular Hypertension; Pathological Conditions, Anatomical; Glaucoma; Glaucoma, Open-Angle; Refractive Errors; Eye Diseases; Myopia; Atrophy
• Other Study ID Numbers: 2023KYPJ105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No