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Biomechanics of Optic Neuropathy

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ClinicalTrials.gov Identifier: NCT02982499
Recruitment Status : Terminated (Principal investigator's decision due to lack of resources)
First Posted : December 5, 2016
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Byron Lam, 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.

Condition or disease Intervention/treatment
Optic Neuropathy Device: magnetic resonance image (MRI) Device: Optical Coherence Tomography (OCT)

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomechanics of Optic Neuropathy
Actual Study Start Date : September 2016
Actual Primary Completion Date : March 26, 2018
Actual Study Completion Date : March 26, 2018


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)




Primary Outcome Measures :
  1. Globe deformation [ Time Frame: 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 :
  1. intracranial pressure [ Time Frame: Day 1 ]
    Intracranial pressure will be measured using non invasive MRI.

  2. Corneal thickness [ Time Frame: 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.

  3. Visual field defect [ Time Frame: Day 1 ]
    Humphrey Field Analyzer II will be used to acquire the Mean deviation(MD).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982499


Locations
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United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Byron R Lam, MD University of Miami
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Responsible Party: Byron Lam, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02982499    
Other Study ID Numbers: 20160376
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Byron Lam, University of Miami:
glaucoma
Leber optic neuropathy
anterior ischemic optic neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Optic Nerve Diseases
Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases