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

NCT03553017 | Completed

• 1 other identifier: 17/0839
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Diseases; Eye Infections; Eye Inflammation

Keywords

Optical Coherence Tomography; Automated; Binocular

Outcome Measures

Primary Outcomes (1)

• Repeatability of the binocular OCY

  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.

  2 years

Secondary Outcomes (1)

• Comparison with other devices

  2 years

Study Arms (1)

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.

Device: Binocular OCT

Interventions

Binocular OCT DEVICE

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

Participants with eye disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Moorfields Eye Hospital NHS FT

London, EC1V 2PD, United Kingdom

Location

Related Publications (2)

• Chopra R, Mulholland PJ, Dubis AM, Anderson RS, Keane PA. Human Factor and Usability Testing of a Binocular Optical Coherence Tomography System. Transl Vis Sci Technol. 2017 Aug 15;6(4):16. doi: 10.1167/tvst.6.4.16. eCollection 2017 Jul.

  PMID: 28824827 BACKGROUND

• Walsh AC. Binocular optical coherence tomography. Ophthalmic Surg Lasers Imaging. 2011 Jul;42 Suppl:S95-S105. doi: 10.3928/15428877-20110627-09.

  PMID: 21790117 BACKGROUND

MeSH Terms

Conditions

Eye Diseases; Eye Infections; Endophthalmitis

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: May 22, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

GB (1)