Clinical trial NCT02441777: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: retinal imaging
optical imaging
optical coherence tomography
polarization sensitive coherence tomography
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Eye and Ear Infirmary
First posted: 2015-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Average nerve fiber layer (NFL) birefringence
timeFrame: At time of imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Benjamin Vakoc, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: