Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal Imaging
|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: NCT02441777|
Recruitment Status : Not yet recruiting
First Posted : May 12, 2015
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: Polarization-Sensitive OFDI||Not Applicable|
Glaucoma is the second leading cause of blindness in the world. The current clinical standard-of-care procedure to diagnose glaucoma is visual field testing with disc photography. Visual field testing is subjective both in the patient's feedback and the physician's interpretation of this feedback, and disc photography requires a physician's subjective interpretation. As a result, it is estimated that current methods can diagnose glaucoma only after 40% of the nerve fiber layer (NFL) has been lost. Since glaucoma leads to significant changes in both NFL thickness and NFL optical birefringence, non-invasive imaging of these properties could potentially enable diagnosis of glaucoma prior to changes in vision. Optical Coherence Tomography (OCT) is routinely used in retinal imaging, and its ability to detect changes in NFL health is being actively studied. To detect NFL optical birefringence, a specialized variation of OCT termed polarization sensitive OCT (PS-OCT) is required. Because of high noise in PS-OCT images, prior studies have been unable to detect NFL changes in birefringence.
We have recently developed new methods for performing highly sensitive polarization-sensitive OCT. These changes are algorithmic in nature, and use the same optical wavelengths and powers as clinically deployed OCT retinal imaging instruments. In benchtop studies, these algorithmic changes improve the signal-to-noise ratio (SNR) of PS-OCT images. We propose to conduct a pilot study in normal, healthy subjects to evaluate if these changes improve the SNR of NFL birefringence images.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal Imaging|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Control: Healthy
Polarization Sensitive Optical Coherence Tomography (PS-OCT) Imaging will be used to look at the nerve fiber layer (NFL) in the healthy retina.
Device: Polarization-Sensitive OFDI
OCT Imaging of the eye
- Average nerve fiber layer (NFL) birefringence [ Time Frame: At time of imaging ]Measured birefringence values will be compared to normative values from literature
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): NCT02441777
|Contact: Benjamin Vakoc, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Benjamin Vakoc, Ph.D.|
|Principal Investigator:||Benjamin Vakoc, Ph.D.||Massachusetts General Hospital|