Biomechanics of Optic Neuropathy

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.

Study Overview

• Status: Terminated
• Conditions: Optic Neuropathy
• Intervention / Treatment: Device: magnetic resonance image (MRI); Device: Optical Coherence Tomography (OCT)

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Case group: Patients with optic neuropathy who are 18 years or older Control group: age-matched healthy subjects

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group; Healthy participants will receive a one-time assessment of quantitative Magnetic Resonance Imaging (MRI) and spectrum domain optical coherence tomography (OCT).	Device: magnetic resonance image (MRI); Radiographic imaging that takes about 30-45 minutes; Device: Optical Coherence Tomography (OCT); Images taken from the back of the eye (retina)
optic neuropathy group; Participants with optic neuropathy will receive a one-time assessment of quantitative Magnetic Resonance Imaging (MRI) and spectrum domain optical coherence tomography (OCT).	Device: magnetic resonance image (MRI); Radiographic imaging that takes about 30-45 minutes; Device: Optical Coherence Tomography (OCT); Images taken from the back of the eye (retina)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Byron R Lam, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): March 26, 2018
• Study Completion (Actual): March 26, 2018

Study Registration Dates

• First Submitted: August 28, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: glaucoma; Leber optic neuropathy; anterior ischemic optic neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neuromuscular Diseases; Cranial Nerve Diseases; Peripheral Nervous System Diseases; Optic Nerve Diseases
• Other Study ID Numbers: 20160376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No