GlaucomaNCT04610008
Optic Nerve Head Shape as a Predictor of the Formation of Acquired Pits of the Optic Nerve (APONs)
An observational study of Glaucoma, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
Acquired pits of the optic nerve (APONs) are an area of focal loss of neural tissue associated with a discrete area of depression/excavation within the optic cup at the level of the lamina cribrosa. It is commonly associated with glaucoma and can be seen on the optic disc when examining the back of a patient's eye. Read more about this study
- Who is it for?
- Ages 50 to 110 years
- Conditions the study is for
- Glaucoma
- How many people
- 91 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2020to 25 Jan 2021
- 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 50 to 110 years
- All sexes
- Adult, Older adult
Study population: Patients under the care of University Hospital of Wales Ophthalmology Department with optic nerve head photographs taken as part of routine clinical care for monitoring of glaucoma.
Who may be able to join
- Documented diagnosis of primary open angle glaucoma (POAG) or normal tension glaucoma (NTG)
- Under the care of the ophthalmology department at University Hospital of Wales
- Available optic disc photograph
- Presence of an APON for disease group, no APON for control group
Who cannot join
- No documented diagnosis of POAG/NTG
- Other form of glaucoma - e.g. traumatic glaucoma/juvenile glaucoma
- Poor photograph quality
- Optic disc tilted so that the margin is obscured and cannot be demarcated
- Coexisting disc pathology, e.g. congenital optic disc pit
Trial locations and contacts
1 site in 1 country.
About this study
Acquired pits of the optic nerve (APONs) are an area of focal loss of neural tissue associated with a discrete area of depression/excavation within the optic cup at the level of the lamina cribrosa. It is commonly associated with glaucoma and can be seen on the optic disc when examining the back of a patient's eye. It causes a characteristic visual field defect in the central 5-10 degrees of vision which has a significant impact of a patient's daily activities. There is no treatment to restore vision once it has formed.
Previous studies suggest mechanical stress across this part of the eye may have role in the formation of APONs. The investigators therefore hypothesise that if a patient has a more elliptical shaped optic disc, which would have more irregular mechanical stress across it, it may have a higher risk of an APON forming.
Read more
Patients with glaucoma attending the ophthalmology department at University Hospital of Wales have regular photographs taken of the optic nerve/optic disc as part of their routine clinical care in order to monitor the condition. The research team, who are all practicing ophthalmologists in the department, will review anonymised photographs to find optic discs with APONs, and another group with glaucoma but no APONs to use as a control. The research team will then measure the dimensions of the optic disc to determine if APONs are more common in optic discs with a more elliptical shape. The patients' clinical notes will then need to be accessed to collect data on the age, sex and diagnosis. This data will be anonymised using ID numbers once collected.
The final outcomes of the study will the average measured dimensions of the optic disc in each group, and the position that the APON occurs.
- Conditions
- Glaucoma
- Being tested
- No intervention. Purely observation
- Keywords
- Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Purely observationOther
Retrospective image analysis of the shape of the optic nerve head in both groups
| Study group | Role | What they receive |
|---|---|---|
| APON | Retrospective review of routine clinical images from patients with an acquired pit of the optic nerve (APON), and a documented diagnosis of primary open angle glaucoma or normal tension glaucoma Receives: Other: No intervention. Purely observation | |
| No APON control | Retrospective review of routine clinical images from patients with NO acquired pit of the optic nerve (APON), and a documented diagnosis of primary open angle glaucoma or normal tension glaucoma Receives: Other: No intervention. Purely observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic disc radius ratio
Comparison of the ratio of the maximum/minimum optic disc radius for optic discs with APONs and optic discs with glaucoma but no APON.
Measured: 6 months
Secondary outcomes (1)
The percentile rank of the disc radius at the position of the APON
The percentile rank of the disc radius at the position of the APON
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 Dec 2020
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610008
- Sponsor's protocol ID
- 7943
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Head Shape as a Predictor of the Formation of Acquired Pits of the Optic Nerve (APONs)
- ClinicalTrials.gov ID
- NCT04610008
- Acronym / sponsor ID
- 7943
- Conditions
- Glaucoma
- Keywords
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 30 Oct 2020 (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.
Acquired pits of the optic nerve (APONs) are an area of focal loss of neural tissue associated with a discrete area of depression/excavation within the optic cup at the level of the lamina cribrosa. It is commonly associated with glaucoma and can be seen on the optic disc when examining the back of a patient's eye. It causes a characteristic visual field defect in the central 5-10 degrees of vision which has a significant impact of a patient's daily activities. There is no treatment to restore vision once it has formed.
Previous studies suggest mechanical stress across this part of the eye may have role in the formation of APONs. The investigators therefore hypothesise that if a patient has a more elliptical shaped optic disc, which would have more irregular mechanical stress across it, it may have a higher risk of an APON forming.
Patients with glaucoma attending the ophthalmology department at University Hospital of Wales have regular photographs taken of the optic nerve/optic disc as part of their routine clinical care in order to monitor the condition. The research team, who are all practicing ophthalmologists in the department, will review anonymised photographs to find optic discs with APONs, and another group with glaucoma but no APONs to use as a control. The research team will then measure the dimensions of the optic disc to determine if APONs are more common in optic discs with a more elliptical shape. The patients' clinical notes will then need to be accessed to collect data on the age, sex and diagnosis. This data will be anonymised using ID numbers once collected.
The final outcomes of the study will the average measured dimensions of the optic disc in each group, and the position that the APON occurs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APON | – | Other: No intervention. Purely observationRetrospective review of routine clinical images from patients with an acquired pit of the optic nerve (APON), and a documented diagnosis of primary open angle glaucoma or normal tension glaucoma |
| No APON control | – | Other: No intervention. Purely observationRetrospective review of routine clinical images from patients with NO acquired pit of the optic nerve (APON), and a documented diagnosis of primary open angle glaucoma or normal tension glaucoma |
Who may qualify
- Ages
- 50 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients under the care of University Hospital of Wales Ophthalmology Department with optic nerve head photographs taken as part of routine clinical care for monitoring of glaucoma.
Key inclusion criteria (4 listed)
- Documented diagnosis of primary open angle glaucoma (POAG) or normal tension glaucoma (NTG)
- Under the care of the ophthalmology department at University Hospital of Wales
- Available optic disc photograph
- Presence of an APON for disease group, no APON for control group
Key exclusion criteria (5 listed)
- No documented diagnosis of POAG/NTG
- Other form of glaucoma - e.g. traumatic glaucoma/juvenile glaucoma
- Poor photograph quality
- Optic disc tilted so that the margin is obscured and cannot be demarcated
- Coexisting disc pathology, e.g. congenital optic disc pit
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 |
|---|---|---|
| No intervention. Purely observationRetrospective image analysis of the shape of the optic nerve head in both groups | Other | APON, No APON control |
Primary outcome
Optic disc radius ratio
Time frame: 6 months
Comparison of the ratio of the maximum/minimum optic disc radius for optic discs with APONs and optic discs with glaucoma but no APON.
1 secondary outcome
The percentile rank of the disc radius at the position of the APON
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Glaucoma, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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 5 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: finished, as of the sponsor's last update on 18 Feb 2021. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic disc radius ratio (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2021.