Biomechanics of Optic Neuropathy

NCT02982499 — Terminated, 10 participants, University of Miami

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Registry	NCT02982499
Status	Terminated - Principal investigator's decision due to lack of resources
Study type	Observational
Enrollment	10 (Actual)
Sponsor	University of Miami (Other)
Conditions	Optic Neuropathy
Interventions	magnetic resonance image (MRI), Optical Coherence Tomography (OCT) (Device)
Dates	start 2016-09-01, primary completion 2018-03-26, completion 2018-03-26, first posted 2016-12-05, last updated 2020-10-23
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
control group		Device: magnetic resonance image (MRI); Device: Optical Coherence Tomography (OCT)	Healthy participants will receive a one-time assessment of quantitative Magnetic Resonance Imaging (MRI) and spectrum domain optical coherence tomography (OCT).
optic neuropathy group		Device: magnetic resonance image (MRI); Device: Optical Coherence Tomography (OCT)	Participants with optic neuropathy will receive a one-time assessment of quantitative Magnetic Resonance Imaging (MRI) and spectrum domain optical coherence tomography (OCT).

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

+Outcome measures

Primary outcomes

Globe deformation [day 1]: 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.

Secondary outcomes

intracranial pressure [Day 1]: Intracranial pressure will be measured using non invasive MRI.
Corneal thickness [Day 1]: 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.
Visual field defect [Day 1]: Humphrey Field Analyzer II will be used to acquire the Mean deviation(MD).

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Bascom Palmer Eye Institute	Miami, Florida	United States

+Investigators

Byron R Lam, MD, Principal investigator, University of Miami