Effect of Peripapillary Atrophy to Diagnose Glaucoma in High Myopia

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05964634

Collaborator

(none)

120

Enrollment

Location

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myopia Refractive Errors Eye Diseases Glaucoma, Primary Open Angle Peripapillary Atrophy	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 Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2024

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Demographic characteristics [1 day of enrollment]
Including but not limited to gender, age, duration of illness
blood pressure [1 day of enrollment]
Demographic characteristics
BMI [1 day of enrollment]
weight (lb) / [height (in)]2
Best corrected visual acuity [1 day of enrollment]
Best corrected visual acuity after refractive error correction using the ETDRS chart
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
Axial length [1 day of enrollment]
axial length is measured using A-type ultrasound.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age ≥18 years.
Equivalent spherical ≤-6D or axial length ≥26.5mm.
High myopia with primary open angle glaucoma, such as anterior chamber angle is opening, optic rim defect, RNFL loss, etc.
The peripapillary region can be accurately defined Based on OCT.

Exclusion Criteria:

(1) Exclusion criteria for high myopia group:

History of glaucoma and elevated intraocular pressure.
History of uveitis or intraocular surgery.
History of other retinal optic nerve or related systemic diseases.
The examination results are unreliable, such as poor image quality.

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

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