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Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal Imaging

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

Tracking Information
First Submitted Date  ICMJE April 27, 2015
First Posted Date  ICMJE May 12, 2015
Last Update Posted Date March 6, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2015)
Average nerve fiber layer (NFL) birefringence [ Time Frame: At time of imaging ]
Measured birefringence values will be compared to normative values from literature
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02441777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal Imaging
Official Title  ICMJE Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal Imaging
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Healthy
Intervention  ICMJE Device: Polarization-Sensitive OFDI
OCT Imaging of the eye
Other Names:
  • Optical Imaging
  • Optical Coherence Tomography
  • OCT
  • Optical Frequency Domain Imaging
Study Arms  ICMJE 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.
Intervention: Device: Polarization-Sensitive OFDI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Benjamin Vakoc, PhD 617-726-0695 bvakoc@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02441777
Other Study ID Numbers  ICMJE 2014P001042
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benjamin Vakoc, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Massachusetts Eye and Ear Infirmary
Investigators  ICMJE
Principal Investigator: Benjamin Vakoc, Ph.D. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP