NCT05964634

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

May 11, 2023

Last Update Submit

July 27, 2023

Conditions

MyopiaRefractive ErrorsEye DiseasesGlaucoma, Primary Open AnglePeripapillary Atrophy

Keywords

high myopiaglaucomaPeripapillary AtrophyOptical Coherence Tomography

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Demographic characteristics

    1 day of enrollment

  • blood pressure

    1 day of enrollment

  • BMI

    1 day of enrollment

  • Best corrected visual acuity

    1 day of enrollment

  • Evaluation of the intraocular pressure changes within 12 mouths

    1 year

  • +4 more secondary outcomes

Study Arms (2)

myopic glaucoma

Patiens who have high myopia with primary open angle glaucoma

Diagnostic Test: OCT imaging

healthy myopia

Patiens who have high myopia without primary open angle glaucoma

Diagnostic Test: OCT imaging

Interventions

OCT imagingDIAGNOSTIC_TEST

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 myopiamyopic glaucoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have high myopia with or without glaucoma.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

  • 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.

    PMID: 23462744BACKGROUND

  • 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.

    PMID: 33309588BACKGROUND

Related Links

MeSH Terms

Conditions

MyopiaRefractive ErrorsEye DiseasesGlaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension

Central Study Contacts

Yiqing Li

CONTACT

+86 13302235127liyiqing@gzzoc.com

Jinpeng Yang

CONTACT

+86 18595813993yangjp35@mail2.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate research fellow

Study Record Dates

First Submitted

May 11, 2023

First Posted

July 28, 2023

Study Start

August 1, 2023

Primary Completion

November 30, 2024

Study Completion

January 31, 2025

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)