Skip to main content
OpenTrials
Completed

NCT Number: NCT04610008

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention. Purely observation

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. The percentile rank of the disc radius at the position of the APON

    Time frame: 6 months

    The percentile rank of the disc radius at the position of the APON

Sponsors and collaborators

Lead sponsor

Cardiff and Vale University Health Board

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2020
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.