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

• ClinicalTrials.gov Identifier: NCT04610008
• Recruitment Status: Completed
• First Posted: October 30, 2020
• Last Update Posted: February 18, 2021
• Sponsor: Cardiff and Vale University Health Board
• Information provided by (Responsible Party): Cardiff and Vale University Health Board

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
Glaucoma	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: December 1, 2020
• Actual Primary Completion Date: January 25, 2021
• Actual Study Completion Date: January 25, 2021

Groups and Cohorts

Group/Cohort	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 [ 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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 110 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

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.

Criteria

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

United Kingdom

University Hospital of Wales

Cardiff, United Kingdom, CF14 4XW

Sponsors and Collaborators

Cardiff and Vale University Health Board

More Information

• Responsible Party: Cardiff and Vale University Health Board
• ClinicalTrials.gov Identifier: NCT04610008
• Other Study ID Numbers: 7943
• First Posted: October 30, 2020
• Last Update Posted: February 18, 2021
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• 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:

Glaucoma

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Eye Diseases