Biomechanics of Optic Neuropathy

Terminated

• Conditions: Optic Neuropathy
• Interventions: Device: magnetic resonance image (MRI); Device: Optical Coherence Tomography (OCT)

• Registration Number: NCT02982499
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-28
• Study Start: 2016-09
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Primary Completion: 2018-03-26
• Study Completion: 2018-03-26
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	magnetic resonance image (MRI)	Healthy participants will receive a one-time assessment of quantitative Magnetic Resonance Imaging (MRI) and spectrum domain optical coherence tomography (OCT).
optic neuropathy group	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).
control group	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	magnetic resonance image (MRI)	Participants with optic neuropathy will receive a one-time assessment of quantitative Magnetic Resonance Imaging (MRI) and spectrum domain optical coherence tomography (OCT).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
intracranial pressure	Day 1	Intracranial pressure will be measured using non invasive MRI.
Visual field defect	Day 1	Humphrey Field Analyzer II will be used to acquire the Mean deviation(MD).
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.

Trial Locations

Locations (1)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States