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

Sponsor
Cardiff and Vale University Health Board (Other)
Overall Status
Completed
CT.gov ID
NCT04610008
Collaborator
(none)
91
1
1.8
50.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention. Purely observation

Study Design

Study Type:
Observational
Actual Enrollment :
91 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Optic Nerve Head Shape as a Predictor of the Formation of Acquired Pits of the Optic Nerve (APONs)
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Jan 25, 2021
Actual Study Completion Date :
Jan 25, 2021

Arms and Interventions

Arm Intervention/Treatment
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

Other: No intervention. Purely observation
Retrospective image analysis of the shape of the optic nerve head in both groups

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

Other: No intervention. Purely observation
Retrospective image analysis of the shape of the optic nerve head in both groups

Outcome Measures

Primary Outcome Measures

  1. Optic disc radius ratio [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 Outcome Measures

  1. The percentile rank of the disc radius at the position of the APON [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 110 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Wales Cardiff United Kingdom CF14 4XW

Sponsors and Collaborators

  • Cardiff and Vale University Health Board

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cardiff and Vale University Health Board
ClinicalTrials.gov Identifier:
NCT04610008
Other Study ID Numbers:
  • 7943
First Posted:
Oct 30, 2020
Last Update Posted:
Feb 18, 2021
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cardiff and Vale University Health Board
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2021