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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00999934
Other study ID # eyemovements01
Secondary ID
Status Recruiting
Phase N/A
First received October 21, 2009
Last updated January 10, 2017
Start date July 2009
Est. completion date February 2018

Study information

Verified date April 2016
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics CommissionIsrael: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

The purpose of eye movements is to ensure clear, optimal vision. In order to see clearly, images must be held steady on the retina. Best visual acuity is achieved when the image of the object of interest is brought to and held on the fovea of the retina. Two main types of eye movements are responsible for that: those that keep images stable on the retina (gaze holding mechanisms) and those that change the line of sight (gaze shifting mechanisms). Several functional classes of eye movements have been defined; each has distinctive physiological properties that suit best to its particular task. Thus, vestibular and optokinetic eye movements hold images of the seen world steady on the retina during perturbations of the head. Saccades are rapid eye movements that bring the image of an object of interest, detected in the periphery of vision, onto the fovea where it can be seen best. Smooth pursuit eye movements place the images of a moving target close to fovea. Vergence eye movements place the images of a single object simultaneously onto both foveae.

Each functional class of eye movements relies on a different neural substrate. The clinical significance of it is that impairment of a specific class of eye movement points to involvement of distinct structures or pathways within the brain. Thus, abnormalities of ocular motility are often the clue to the anatomical localization of neurological disorders.

Significance: This study will contribute to understand how the brain governs production of eye movements, and provide better insight on interaction between sensory (visual) and motor (eye movement) system, i.e. sensory-motor interaction. It will also contribute to identify pathophysiological mechanisms underlying human diseases and will improve the investigators' ability to diagnose and encourage development of new therapeutic strategies.

Methods: The investigators will measure eye and head movements using the magnetic scleral search coil technique. The magnetic search coil technique is the most sensitive and accurate technique used in modern ocular motor and vestibular research for measuring horizontal, vertical and torsional eye movements. The coils are easy to apply and well tolerated over a wearing period of up to 45 minutes per recording session.

Population: A grand total of about 250 individuals (normal subjects and patients) will be recruited for the study. Patients will be recruited from the in- and out-patients of the Neurology and Neuro-ophthalmology services of Meir Medical Center. Healthy normal subjects will be recruited from faculty and staff of Meir Medical Center.

Criteria for inclusion/exclusion: The investigators will study patients with neurological disorders causing abnormal eye movements: Degenerative CNS diseases, extrapyramidal disorders, Spino-cerebellar ataxias, Cerebrovascular diseases, demyelinating diseases, Ocular motor and vestibular palsies, Mitochondrial and other ocular myopathies. Only patients who are medically stable and are able to give informed consent will be included in the study. Criteria for excluding subjects will include eye disease such as corneal or scleral abrasion or disease, glaucoma, refractive errors greater than 2 diopters and concurrent medication with CNS-active agents.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date February 2018
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients with degenerative CNS diseases, extrapyramidal disorders, Spino-cerebellar ataxias, Cerebrovascular diseases, demyelinating diseases, Ocular motor and vestibular palsies, Mitochondrial and other ocular myopathies.

- Patients who are medically stable and are able to give informed consent will be included in the study.

Exclusion Criteria:

- Subjects with eye disease such as corneal or scleral abrasion or disease, glaucoma, refractive errors greater than 2 diopters.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Department of Neurology Kfar Saba

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantitative measure of eye movement and vestibulo-ocular abnormalities December 1, 2012 No