Biomechanics of Optic Neuropathy

NCT02982499 | Terminated FDA Device

• 1 other identifier: 20160376
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Optic Neuropathy

Keywords

glaucoma; Leber optic neuropathy; anterior ischemic optic neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• intracranial pressure

  Day 1

• Corneal thickness

  Day 1

• Visual field defect

  Day 1

Study Arms (2)

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); Device: Optical Coherence Tomography (OCT)

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); Device: Optical Coherence Tomography (OCT)

Interventions

magnetic resonance image (MRI) DEVICE

Radiographic imaging that takes about 30-45 minutes

control group; optic neuropathy group

Optical Coherence Tomography (OCT) DEVICE

Images taken from the back of the eye (retina)

control group; optic neuropathy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Optic Nerve Diseases; Glaucoma; Optic Atrophy, Hereditary, Leber; Optic Neuropathy, Ischemic

Interventions

Magnetic Resonance Imaging; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Ocular Hypertension; Optic Atrophies, Hereditary; Optic Atrophy; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, Optical; Optical Imaging; Investigative Techniques

Study Officials

• Byron R Lam, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2016
• First Posted: December 5, 2016
• Study Start: September 1, 2016
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)