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

NCT02441777 | Not Yet Recruiting

• 1 other identifier: 2014P001042
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

retinal imaging; optical imaging; optical coherence tomography; polarization sensitive coherence tomography

Outcome Measures

Primary Outcomes (1)

• Average nerve fiber layer (NFL) birefringence

  Measured birefringence values will be compared to normative values from literature

  At time of imaging

Study Arms (1)

Control: Healthy

EXPERIMENTAL

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

Interventions

Polarization-Sensitive OFDI DEVICE

OCT Imaging of the eye

Also known as: Optical Imaging, Optical Coherence Tomography, OCT, Optical Frequency Domain Imaging

Control: Healthy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Eye and Ear Infirmary: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Optical Imaging; Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Tomography, Optical; Tomography

Study Officials

• Benjamin Vakoc, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Vakoc, PhD

CONTACT

617-726-0695; bvakoc@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 12, 2015
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

US (1)