Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal Imaging
Primary Purpose
Healthy
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Polarization-Sensitive OFDI
Sponsored by
About this trial
This is an interventional device feasibility trial for Healthy focused on measuring retinal imaging, optical imaging, optical coherence tomography, polarization sensitive coherence tomography
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects between the ages of 18-85 years
- Healthy normal subjects with no significant eye disease, except for mild cataracts
- Subjects with clear enough cornea or clear enough media to permit imaging
- Subjects with refractive error between -5.00 sph to +5.00 sph
Exclusion Criteria:
- Subjects who have occludable narrow angles (without a patent peripheral iridotomy) or any other ocular or systemic pathology, which precludes safe dilation
- Subjects whose eyes have been dilated for over 6 hours will not be eligible for imaging.
- Subjects who do not or cannot understand the instructions for the PS-OCT imaging
- Subjects who are pregnant and/or breastfeeding. Date of last menstrual cycle will also be included.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Control: Healthy
Arm Description
Polarization Sensitive Optical Coherence Tomography (PS-OCT) Imaging will be used to look at the nerve fiber layer (NFL) in the healthy retina.
Outcomes
Primary Outcome Measures
Average nerve fiber layer (NFL) birefringence
Measured birefringence values will be compared to normative values from literature
Secondary Outcome Measures
Full Information
NCT ID
NCT02441777
First Posted
April 27, 2015
Last Updated
March 23, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Eye and Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT02441777
Brief Title
Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal Imaging
Official Title
Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Eye and Ear Infirmary
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
retinal imaging, optical imaging, optical coherence tomography, polarization sensitive coherence tomography
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control: Healthy
Arm Type
Experimental
Arm Description
Polarization Sensitive Optical Coherence Tomography (PS-OCT) Imaging will be used to look at the nerve fiber layer (NFL) in the healthy retina.
Intervention Type
Device
Intervention Name(s)
Polarization-Sensitive OFDI
Other Intervention Name(s)
Optical Imaging, Optical Coherence Tomography, OCT, Optical Frequency Domain Imaging
Intervention Description
OCT Imaging of the eye
Primary Outcome Measure Information:
Title
Average nerve fiber layer (NFL) birefringence
Description
Measured birefringence values will be compared to normative values from literature
Time Frame
At time of imaging
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female subjects between the ages of 18-85 years
Healthy normal subjects with no significant eye disease, except for mild cataracts
Subjects with clear enough cornea or clear enough media to permit imaging
Subjects with refractive error between -5.00 sph to +5.00 sph
Exclusion Criteria:
Subjects who have occludable narrow angles (without a patent peripheral iridotomy) or any other ocular or systemic pathology, which precludes safe dilation
Subjects whose eyes have been dilated for over 6 hours will not be eligible for imaging.
Subjects who do not or cannot understand the instructions for the PS-OCT imaging
Subjects who are pregnant and/or breastfeeding. Date of last menstrual cycle will also be included.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Vakoc, PhD
Phone
617-726-0695
Email
bvakoc@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Vakoc, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Vakoc, Ph.D.
12. IPD Sharing Statement
Learn more about this trial
Polarization Sensitive Optical Coherence Tomography (PS-OCT) for Retinal Imaging
We'll reach out to this number within 24 hrs