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

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ClinicalTrials.gov Identifier: NCT03553017
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University College, London

Tracking Information
First Submitted Date May 29, 2018
First Posted Date June 12, 2018
Last Update Posted Date October 19, 2020
Actual Study Start Date May 22, 2018
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2018)
Repeatability of the binocular OCY [ Time Frame: 2 years ]
The primary objective will be to assess the repeatability of quantifying various parameters in images acquired using a prototype binocular OCT system. This will be explored in different diseases.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 29, 2018)
Comparison with other devices [ Time Frame: 2 years ]
The secondary objective will be to compare to other imaging modalities and describe novel features across a range of ocular diseases.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The EXPLORE Study - The Use of Binocular OCT Imaging for the Assessment of Ocular Disease
Official Title A Prospective Single-Site Non-Interventional Exploratory Study Using a Prototype Binocular Optical Coherence Tomography System for Imaging of Ocular Disease
Brief 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.

Detailed Description

Imaging of the retina using OCT is the commonest ophthalmic imaging procedure worldwide - in 2011, it is estimated that more than 20 million retinal OCT images were obtained, more than the sum of all other ophthalmic imaging procedures combined).4 OCT is also used to image the anterior segment, particularly to measure corneal thickness, in glaucoma to measure the irido-corneal angle, 5 and more recently to measure cells in ocular inflammatory conditions. In addition, vitreous imaging may be useful to measure cells in the posterior chamber.

Most OCT systems are dedicated to retinal imaging or anterior segment imaging. Some commercial retinal scanners are capable of switching between anterior and posterior imaging modes with additional optical attachments, however anterior segment imaging performance is typically suboptimal in these instruments. A key feature of the Binocular OCT is that it can perform 'whole-eye' OCT imaging spanning from the eyelids to the posterior pole in a single instrument without the requirement of additional attachments, and in an automated way.

This study will determine whether the instrument can be used for patients with different eye diseases. The investigators anticipate recruiting approximately 100 participants with anterior eye conditions such as keratoconus, acute anterior uveitis, and pigment dispersion syndrome, in addition to approximately 100 participants with posterior segment eye conditions such as diabetic retinopathy, age-related macular degeneration, and glaucoma.

As this device can image many structures of the eye and with a greater depth range than most commercial OCT devices, it may be possible to visualise features not previously imaged with other devices such as vitreous imaging, or imaging of cells in the ocular inflammatory conditions. In this study, the prototype binocular OCT system will be used to describe novel features across a range of ocular diseases. Qualitative analyses of raw binocular OCT images will be performed (including assessments of retinal pathological features, corneal and anterior chamber morphology, lens status, iris dynamics, and ocular inflammatory cells). These parameters will be correlated with findings from other non-invasive ocular imaging previously obtained during routine clinical care. Although raw OCT images can be useful for diagnosis, quantitative data from the images are useful to monitor eye disease. Commercial OCT devices have built-in software packages to analyse OCT images to provide the clinician with parameters for detecting and monitoring eye disease. Quantitative analysis of binocular OCT images will be performed using MATLAB (The MathWorks, Inc., Natick, Massachusetts, United States).

In addition, the ability to combine structural and functional assessments in the same instrument may permit better examinations of ophthalmic disease compared to separate clinical tests. This study will also permit future studies to be correctly powered.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with various eye diseases will be recruited from appropriate eye clinics at Moorfields Eye Hospital. Eye conditions will include both anterior segment disease such as corneal disease and ocular inflammatory disease, retinal vascular and macular diseases, and optic nerve disease such as glaucoma.
Condition
  • Eye Diseases
  • Eye Infections
  • Eye Inflammation
Intervention 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.).
Study Groups/Cohorts Participants with eye disease
A maximum of 200 participants with various eye diseases will be recruited from appropriate eye clinics at Moorfields Eye Hospital. Eye conditions will include both anterior segment disease such as corneal disease and ocular inflammatory disease, retinal vascular and macular diseases, and optic nerve disease such as glaucoma.
Intervention: Device: Binocular OCT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 15, 2020)
70
Original Estimated Enrollment
 (submitted: May 29, 2018)
200
Actual Study Completion Date March 1, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Presence of ocular disease that can be imaged using optical coherence tomography
  • Male or female, aged 18 years or older
  • Ability to understand nature/purpose of the study and to provide informed consent
  • Ability to undergo binocular OCT imaging
  • Ability to follow instructions and complete the study
  • Ability to speak English

Exclusion Criteria:

  • Optical media opacity sufficient to preclude adequate ocular imaging with OCT
  • Hearing impairment sufficient to interfere with hearing instructions
  • Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03553017
Other Study ID Numbers 17/0839
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University College, London
Study Sponsor University College, London
Collaborators National Institute for Health Research, United Kingdom
Investigators Not Provided
PRS Account University College, London
Verification Date October 2020