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Optic Nerve Head Shape as a Predictor of the Formation of Acquired Pits of the Optic Nerve (APONs)

Optic Nerve Head Shape as a Predictor of the Formation of Acquired Pits of the Optic Nerve (APONs)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04610008
Enrollment
91
Registered
2020-10-30
Start date
2020-12-01
Completion date
2021-01-25
Last updated
2021-02-18

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

Conditions

Glaucoma

Keywords

Glaucoma

Brief 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. 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.

Interventions

OTHERNo intervention. Purely observation

Retrospective image analysis of the shape of the optic nerve head in both groups

Sponsors

Cardiff and Vale University Health Board
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 110 Years

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Optic disc radius ratio6 monthsComparison of the ratio of the maximum/minimum optic disc radius for optic discs with APONs and optic discs with glaucoma but no APON.

Secondary

MeasureTime frameDescription
The percentile rank of the disc radius at the position of the APON6 monthsThe percentile rank of the disc radius at the position of the APON

Countries

United Kingdom

Outcome results

None listed

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