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NCT Number: NCT02441777

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

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location contact

Benjamin Vakoc, Ph.D.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polarization-Sensitive OFDI

Device

OCT Imaging of the eye

Other names: Optical Imaging, Optical Coherence Tomography, OCT, Optical Frequency Domain Imaging

Primary outcomes

  1. Average nerve fiber layer (NFL) birefringence

    Time frame: At time of imaging

    Measured birefringence values will be compared to normative values from literature

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Vakoc, PhD

CONTACT

[email protected]

617-726-0695

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Massachusetts Eye and Ear Infirmary

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 12, 2015
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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