Effect of Peripapillary Atrophy to Diagnose Glaucoma in High Myopia

Not yet recruiting

• Conditions: Refractive Errors; Eye Diseases; Myopia; Glaucoma, Primary Open Angle; Peripapillary Atrophy
• Interventions: Diagnostic Test: OCT imaging

• Registration Number: NCT05964634
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief 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

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 Timeline

• Study First Submitted: 2023-05-11
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-27
• Last Update Submitted: 2023-07-27
• Study First Posted: 2023-07-28
• Last Update Posted: 2023-07-28
• Study Start: 2023-08-01
• Primary Completion: 2024-11-30
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy myopia	OCT imaging	Patiens who have high myopia without primary open angle glaucoma
myopic glaucoma	OCT imaging	Patiens who have high myopia with primary open angle glaucoma

Primary Outcome Measures

Name	Time	Method
Evaluation of the area of the peripapillary area changes within 12 months	1 year	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
Evaluation of the width of the peripapillary area changes within 12 months	1 year	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
Evaluation of circumpapillary retinal nerve fiber layer thickness changes within 12 months	1 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China