The EXPLORE Study - The Use of Binocular OCT Imaging for the Assessment of Ocular Disease

NCT03553017 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2020-10-19

No results posted yet for this study

Summary

Optical coherence tomography (OCT) is an imaging modality, first described in 1991, that provides cross-sectional images of the eye in a non-invasive manner. OCT is analogous to ultrasonography but measures the "echoes" of light waves rather than sound and, as a result, generates extremely high-resolution images (\~5 μm axial resolution). Although OCT has already proven revolutionary in ophthalmology, current OCT systems are large, expensive, and require skilled personnel for image acquisition and interpretation. Furthermore, current OCT systems are limited to examination of specific regions of single eyes - for example, separate devices are typically required for anterior segment (e.g., cornea) versus posterior segment (e.g., retina) imaging. A new form of OCT imaging has recently been developed - so-called "binocular" optical coherence tomography (OCT) (Envision Diagnostics, Inc., California).1,2 Binocular OCT addresses many of the short-comings of conventional OCT devices.

Binocular OCT extends the application of OCT devices beyond that of simple, cross- sectional imaging to a diverse array of diagnostic tests. The binocular design also removes the need for additional personnel to perform testing (i.e., the device can be self-operated in an automated manner), and allows for novel testing to be performed that is not possible with monocular imaging. In particular, binocular OCT devices have the potential to perform automated, quantitative pupillary measurements - an entirely novel application for this imaging modality, plus also adds a number of unique capabilities. In particular, binocular OCT removes the need for additional personnel to acquire the images by enabling patients to align the optical axes of the instrument with the optical axes of their own eyes. The system also employs recently developed "swept-source" lasers as its light source, allowing it to see deeper into the eye than conventional OCT systems. Finally, binocular OCT systems allow image capture from both eyes at the same time. This "simultaneous" ocular imaging extends the range of diagnostic testing possible, allowing for features such as pupillometry and ocular motility.

The greatly increased range of imaging for these lasers enables the entire depth of eye tissue to be captured in just a few sequences of images - so- called "whole eye" OCT or "OCT ophthalmoscopy".

In this study, the investigators aim to explore the unique imaging features of the binocular OCT to describe novel features across a range of diseases. The repeatability of quantifying various parameters in the images acquired using the system will be assessed.

Conditions

  • Eye Diseases
  • Eye Infections
  • Eye Inflammation

Interventions

DEVICE

Binocular OCT

Participants in the study will undergo OCT imaging using a prototype binocular OCT imaging system (Envision Diagnostics, Inc., CA) twice to assess repeatability.).

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV
  • University College, London

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-22
Primary Completion
2020-03-01
Completion
2020-03-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03553017 on ClinicalTrials.gov