Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02640339|
Recruitment Status : Recruiting
First Posted : December 28, 2015
Last Update Posted : December 3, 2019
- To determine whether retinal abnormalities, as measured by high definition optical coherence tomography (HD-OCT) and visual electrophysiology techniques can be used as a clinical biomarker to monitor disease progression overtime in patients with Parkinson disease.
- To establish whether these measures can be used to identify patients with PD in the premotor phase.
- To define the rate of progression of retinal abnormalities in PD (both in the motor and premotor stages) for potential use as a clinical outcome measure
|Condition or disease|
|Parkinson Disease Multiple System Atrophy REM Sleep Behavior Disorder Pure Autonomic Failure Dementia With Lewy Bodies|
|Study Type :||Observational|
|Estimated Enrollment :||170 participants|
|Official Title:||Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2021|
Parkinson's disease is a progressive disorder of the nervous system that affects movement. It develops gradually, with alpha-synuclein deposits in neurons which aggregate into Lewy bodies.
Mutiple system atrophy
is a degenerative neurological disorder. MSA is associated with the degeneration of nerve cells in specific areas of the brain. This cell degeneration causes problems with movement, balance, and autonomic functions of the body such as bladder control or blood-pressure regulation. Neuronal death probably occurs as a consequence of alpha-synuclein aggregation in oligodendroglia.
REM sleep behavior disorder
a sleep disorder in which you physically act out vivid, often unpleasant dreams with vocal sounds and sudden, often violent arm and leg movements
dementia with Lewy bodies
causes a progressive decline in mental abilities.
It may also cause visual hallucinations, which generally take the form of objects, people or animals that aren't there. This can lead to unusual behavior such as having conversations with deceased loved ones.
Another indicator of Lewy body dementia may be significant fluctuations in alertness and attention, which may include daytime drowsiness or periods of staring into space. And, like Parkinson's disease, Lewy body dementia can result in rigid muscles, slowed movement and tremors.
Pure autonomic failure
Pure autonomic failure is dysfunction of many of the processes controlled by the autonomic nervous system, such as control of blood pressure•Blood pressure may decrease when people stand, and they may sweat less and may have eye problems, retain urine, become constipated, or lose control of bowel movements
Healthy normals with no neurological involvement
- Retinal nerve fiber layer (RNFL) thickness [ Time Frame: Every 6 months from baseline to 3 years ]The results of the RNFL thickness will be expressed in microns in different zones around the optic nerve: temporal, superior, nasal, inferior and global.
- Retinal ganglion cell layer (GCL) thickness [ Time Frame: Every 6 months from baseline to 3 years ]The results of the GCL thickness will be expressed in microns in different zones around the fovea region: temporal- superior, superior, nasal-superior, nasal inferior, inferior, temporal inferior and global.
- • Visual Acuity [ Time Frame: Every 6 months from baseline to 3 years ]Will be expressed in decimal units
- • Color Discrimination [ Time Frame: Every 6 months from baseline to 3 years ]Will be expressed in decimal units.
- • Pupillometry [ Time Frame: Every 6 months from baseline to 3 years ]Measures will include pupil diameter (expressed in millimeters, in dark and light conditions and the amplitude and velocity of the pupillary response.
- • Videonystagmography [ Time Frame: Every 6 months from baseline to 3 years ]Saccadic velocity and amplitude (expressed in m/seg and degrees) will be measured.
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): NCT02640339
|Contact: Jose M Martinez, MA||212 263 firstname.lastname@example.org|
|Contact: Lucy J Norcliffe-Kaufmann, PhD.||212 263 email@example.com|
|United States, New York|
|New York University School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Anthony Carna, MBA 646-754-4601 firstname.lastname@example.org|
|Principal Investigator: Horacio C Kaufmann, MD|
|Principal Investigator:||Horacio C Kaufmann, MD||NYU Langone Health|