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

NCT04610008 | Completed

• 1 other identifier: 7943
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

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

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

Interventions

No intervention. Purely observation OTHER

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

APON; No APON control

Eligibility Criteria

• Age: 50 Years - 110 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: December 1, 2020
• Primary Completion: January 25, 2021
• Study Completion: January 25, 2021
• Last Updated: February 18, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)