MyopiaNCT05964634
Effect of Peripapillary Atrophy to Diagnose Glaucoma in High Myopia
An observational study of Myopia and Refractive Errors, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Refractive Errors, Eye Diseases
- What is being tested?
- OCT imaging
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who have high myopia with or without glaucoma.
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Effect of Peripapillary Atrophy Based on Optical Coherence Tomography to Diagnose Primary Open Angle Glaucoma in High Myopia
This study intends to analyze the characteristics between peripapillary retinal nerve fiber layer thickness and peripapillary area in high myopia with or without glaucoma
Read the 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.
- Conditions
- Myopia, Refractive Errors, Eye Diseases, Glaucoma, Primary Open Angle, Peripapillary Atrophy
- Being tested
- OCT imaging
- Keywords
- high myopia, glaucoma, Peripapillary Atrophy, Optical Coherence Tomography
- Medical subject headings
- Myopia, Refractive Errors, Eye Diseases, Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| myopic glaucoma | Patiens who have high myopia with primary open angle glaucoma Receives: Diagnostic Test: OCT imaging | |
| healthy myopia | Patiens who have high myopia without primary open angle glaucoma Receives: Diagnostic Test: OCT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 1 year
Secondary outcomes (9)
Demographic characteristics
Including but not limited to gender, age, duration of illness
Measured: 1 day of enrollment
blood pressure
Demographic characteristics
Measured: 1 day of enrollment
BMI
weight (lb) / [height (in)]2
Measured: 1 day of enrollment
Best corrected visual acuity
Best corrected visual acuity after refractive error correction using the ETDRS chart
Measured: 1 day of enrollment
Evaluation of the intraocular pressure changes within 12 mouths
IOP is measured by goldmann tonometer.
Measured: 1 year
Evaluation of the visual field changes within 12 mouths
Assess the degree of visual function damage
Measured: 1 year
Axial length
axial length is measured using A-type ultrasound.
Measured: 1 day of enrollment
Evaluation of the fundus changes within 12 months
Fundus photography uses kowa fundus camera
Measured: 1 year
Ocular anterior segment structure
The ocular anterior segment structure uses lit-lamp biomicroscope
Measured: 1 day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiqing Li, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964634
- Sponsor's protocol ID
- 2023KYPJ105
- Status last verified
- Jul 2023
- First submitted
- 11 May 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23462744Wang 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.
PubMed 33309588
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peripapillary Atrophy Based on Optical Coherence Tomography to Diagnose Primary Open Angle Glaucoma in High Myopia
- ClinicalTrials.gov ID
- NCT05964634
- Acronym / sponsor ID
- 2023KYPJ105
- Conditions
- Myopia, Refractive Errors, Eye Diseases, Glaucoma, Primary Open Angle, Peripapillary Atrophy
- Keywords
- high myopia, glaucoma, Peripapillary Atrophy, Optical Coherence Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myopic glaucoma | – | Diagnostic Test: OCT imagingPatiens who have high myopia with primary open angle glaucoma |
| healthy myopia | – | Diagnostic Test: OCT imagingPatiens who have high myopia without primary open angle glaucoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have high myopia with or without glaucoma.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT imagingImage J or Spectralis OCT built-in software package was used to manually locate and measure the area and width of the temporal parapapillary atrophy. | Diagnostic test | healthy myopia, myopic glaucoma |
Primary outcome
Evaluation of circumpapillary retinal nerve fiber layer thickness changes within 12 months
Time frame: 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
Time frame: 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
Time frame: 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
9 secondary outcomes
Demographic characteristics
Time frame: 1 day of enrollment
blood pressure
Time frame: 1 day of enrollment
BMI
Time frame: 1 day of enrollment
Best corrected visual acuity
Time frame: 1 day of enrollment
Evaluation of the intraocular pressure changes within 12 mouths
Time frame: 1 year
Evaluation of the visual field changes within 12 mouths
Time frame: 1 year
Axial length
Time frame: 1 day of enrollment
Evaluation of the fundus changes within 12 months
Time frame: 1 year
Ocular anterior segment structure
Time frame: 1 day of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 23462744Dai 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.
- Background: PubMed 33309588Wang 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.
- beta zone and gamma zone defined based on OCTLink provided by the sponsor.
- Microstructure of parapapillary atrophyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Refractive Errors, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yiqing Li (+86 13302235127, liyiqing@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of circumpapillary retinal nerve fiber layer thickness changes within 12 months (time frame: 1 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05964634, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.