Biomechanics of Optic Neuropathy

Sponsor
University of Miami (Other)
Overall Status
Terminated
CT.gov ID
NCT02982499
Collaborator
(none)
10
1
18.8
0.5

Study Details

Study Description

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 Phase
  • Device: magnetic resonance image (MRI)
  • Device: Optical Coherence Tomography (OCT)

Study Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Biomechanics of Optic Neuropathy
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Mar 26, 2018
Actual Study Completion Date :
Mar 26, 2018

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. intracranial pressure [Day 1]

    Intracranial pressure will be measured using non invasive MRI.

  2. 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.

  3. Visual field defect [Day 1]

    Humphrey Field Analyzer II will be used to acquire the Mean deviation(MD).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bascom Palmer Eye Institute Miami Florida United States 33136

Sponsors and Collaborators

  • University of Miami

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Byron Lam, Professor, University of Miami
ClinicalTrials.gov Identifier:
NCT02982499
Other Study ID Numbers:
  • 20160376
First Posted:
Dec 5, 2016
Last Update Posted:
Oct 23, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Professor, University of Miami
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2020