Biomechanics of Optic Neuropathy

Optic Neuropathy Clinical Trial

Official title:

Biomechanics of Optic Neuropathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02982499
• Other study ID #: 20160376
• Status: Terminated
• Start date: September 2016
• Est. completion date: March 26, 2018

Study information

• Verified date: October 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The participant is being asked to be a subject in this research study because the participant may have a disorder that can cause optic nerve damage and impairment of his/her visual function which is called optic neuropathies (ON). Optic neuropathy refers to damage to the optic nerve (a "cable" connecting the eyes and the brain to transmit the visual signals) due to any cause.In this study, the investigator is using magnetic resonance imaging (MRI) and ophthalmic measures such as optic coherent tomography(OCT), which are non-invasive imaging tests to measure the changes in eye globe shape ,the flow of blood and brain fluid. It is hoped that this study will provide new knowledge that may allow the investigator to better understand the cause of symptoms associated with optic neuropathy and ways to better monitor what is happening.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 26, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• 18 years old and on

• Patients with optic neuropathy(10) and age controlled healthy subjects(10)

Exclusion Criteria :

• For patients: Subjects with history of neurological or ocular disease other than optic neuropathy and refractory error.

• For healthy control group: History of systemic disease except hypertension.

• Pregnant women and prisoners will be excluded.

Related Conditions & MeSH terms

• Optic Nerve Diseases
• Optic Neuropathy
• Peripheral Nervous System Diseases

Intervention

Device:
• magnetic resonance image (MRI)
Radiographic imaging that takes about 30-45 minutes
• Optical Coherence Tomography (OCT)
Images taken from the back of the eye (retina)

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Globe deformation	Three measures of globe deformation are calculated by using the distance map: 1) optic nerve cupping(ONC), depicting the extent of the nerve head cupping; 2) posterior scleral bowing, depicting the degree of displacement of the posterior wall, and 3) maximal deformation (MD), depicting the combined deformation due to the displacement and the nerve cupping.	day 1
Secondary	intracranial pressure	Intracranial pressure will be measured using non invasive MRI.	Day 1
Secondary	Corneal thickness	Corneal thickness will be measured by corneal pachymetry. After anesthetic numbing drop is placed on the eye, blunt probe will briefly touch the participant's eye to obtain the measurement.	Day 1
Secondary	Visual field defect	Humphrey Field Analyzer II will be used to acquire the Mean deviation(MD).	Day 1