Clinical trial NCT05964634: Effect of Peripapillary Atrophy to Diagnose Glaucoma in High Myopia
Official title: Effect of Peripapillary Atrophy Based on Optical Coherence Tomography to Diagnose Primary Open Angle Glaucoma in High Myopia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myopia
Refractive Errors
Eye Diseases
Glaucoma, Primary Open Angle
Peripapillary Atrophy
Keywords: high myopia
glaucoma
Peripapillary Atrophy
Optical Coherence Tomography
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have high myopia with or without glaucoma.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of circumpapillary retinal nerve fiber layer thickness changes within 12 months
timeFrame: 1 years
measure: Evaluation of the area of the peripapillary area changes within 12 months
timeFrame: 1 year
measure: Evaluation of the width of the peripapillary area changes within 12 months
timeFrame: 1 year
Secondary outcomes:
measure: Demographic characteristics
timeFrame: 1 day of enrollment
measure: blood pressure
timeFrame: 1 day of enrollment
measure: BMI
timeFrame: 1 day of enrollment
measure: Best corrected visual acuity
timeFrame: 1 day of enrollment
measure: Evaluation of the intraocular pressure changes within 12 mouths
timeFrame: 1 year
measure: Evaluation of the visual field changes within 12 mouths
timeFrame: 1 year
measure: Axial length
timeFrame: 1 day of enrollment
measure: Evaluation of the fundus changes within 12 months
timeFrame: 1 year
measure: Ocular anterior segment structure
timeFrame: 1 day of enrollment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: 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.
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.