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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. Identifier: NCT02441777
Recruitment Status : Not yet recruiting
First Posted : May 12, 2015
Last Update Posted : March 6, 2019
Massachusetts Eye and Ear Infirmary
Information provided by (Responsible Party):
Benjamin Vakoc, Massachusetts General Hospital

Brief Summary:
The aim of this pilot study is to assess the ability of a new polarization sensitive optical coherence tomography system to obtain high-quality images of retinal birefringence.

Condition or disease Intervention/treatment Phase
Healthy Device: Polarization-Sensitive OFDI Not Applicable

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Other Names:
  • Optical Imaging
  • Optical Coherence Tomography
  • OCT
  • Optical Frequency Domain Imaging

Primary Outcome Measures :
  1. Average nerve fiber layer (NFL) birefringence [ Time Frame: At time of imaging ]
    Measured birefringence values will be compared to normative values from literature

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Male or female subjects between the ages of 18-85 years
  2. Healthy normal subjects with no significant eye disease, except for mild cataracts
  3. Subjects with clear enough cornea or clear enough media to permit imaging
  4. Subjects with refractive error between -5.00 sph to +5.00 sph

Exclusion Criteria:

  1. Subjects who have occludable narrow angles (without a patent peripheral iridotomy) or any other ocular or systemic pathology, which precludes safe dilation
  2. Subjects whose eyes have been dilated for over 6 hours will not be eligible for imaging.
  3. Subjects who do not or cannot understand the instructions for the PS-OCT imaging
  4. Subjects who are pregnant and/or breastfeeding. Date of last menstrual cycle will also be included.

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 identifier (NCT number): NCT02441777

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Contact: Benjamin Vakoc, PhD 617-726-0695

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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Benjamin Vakoc, Ph.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Massachusetts Eye and Ear Infirmary
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Principal Investigator: Benjamin Vakoc, Ph.D. Massachusetts General Hospital

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Responsible Party: Benjamin Vakoc, Assistant Professor, Massachusetts General Hospital Identifier: NCT02441777     History of Changes
Other Study ID Numbers: 2014P001042
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Benjamin Vakoc, Massachusetts General Hospital:
retinal imaging
optical imaging
optical coherence tomography
polarization sensitive coherence tomography

Additional relevant MeSH terms:
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Immune System Diseases