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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05964634
Enrollment
120
Registered
2023-07-28
Start date
2023-08-01
Completion date
2025-01-31
Last updated
2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Refractive Errors, Eye Diseases, Glaucoma, Primary Open Angle, Peripapillary Atrophy

Keywords

high myopia, glaucoma, Peripapillary Atrophy, Optical Coherence Tomography

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.

Interventions

DIAGNOSTIC_TESTOCT 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.

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of circumpapillary retinal nerve fiber layer thickness changes within 12 months1 yearsThe 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 months1 yearThe 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 months1 yearThe 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

MeasureTime frameDescription
Best corrected visual acuity1 day of enrollmentBest corrected visual acuity after refractive error correction using the ETDRS chart
Evaluation of the intraocular pressure changes within 12 mouths1 yearIOP is measured by goldmann tonometer.
Evaluation of the visual field changes within 12 mouths1 yearAssess the degree of visual function damage
Demographic characteristics1 day of enrollmentIncluding but not limited to gender, age, duration of illness
Evaluation of the fundus changes within 12 months1 yearFundus photography uses kowa fundus camera
Ocular anterior segment structure1 day of enrollmentThe ocular anterior segment structure uses lit-lamp biomicroscope
Axial length1 day of enrollmentaxial length is measured using A-type ultrasound.
blood pressure1 day of enrollmentDemographic characteristics
BMI1 day of enrollmentweight (lb) / \[height (in)\]2

Countries

China

Contacts

Primary ContactYiqing Li
liyiqing@gzzoc.com+86 13302235127
Backup ContactJinpeng Yang
yangjp35@mail2.sysu.edu.cn+86 18595813993

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026